Clinical Operations Jobs in Pharma & Biotech

Responsibilities may include the following and other duties may be assigned. Provides project and/or program support to the Clinical Affairs team. Monitors program/project/system status, document approvals, timelines and budgets as appropriate. Applies knowledge of and experience in company operations to assist in the development, implementation and administration of program/system guidelines and procedures. Applies relevant clinical research support experience to create project related documentation and maintenance. Ensures proper documentation within clinical study management systems and records management. Gathers and compiles information for reports. Provides technical support, which may include program/system training, program/system documentation, data extraction, data review, tracking and shipping and...

With support of Sr.CRA/CRA and/or CRA-Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and related procedures. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. Participates & provides...

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. Immunovant is seeking a Senior Clinical Trial Manager to play a key role on a highly dynamic, cross-functional team. Reporting to the Director, Clinical Operations, you will be responsible for supporting the advancement of rare disease clinical trials as part of Immunovant’s Clinical Operations Team. Key Responsibilities Lead Study Start-up activities, including but not limited to...

Clinical Associate In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises...

With support of Sr.CRA/CRA and/or CRA-Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and related procedures. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. Participates & provides...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Clinical Research Lead (CRL) in the Houston, TX area will manage...

Responsibilities may include the following and other duties may be assigned. Oversees, designs, plans, and develops clinical evaluation research studies. Prepares and authors protocols, clinical plans, start-up, and closure documents. Site training and trending of potential deviations, study events, and monitoring progress. Conducts registered and non-registered clinical studies of products satisfying a medical need and/or offering commercial potential. Oversees and interprets results of clinical investigations in preparation for new drug devices or consumer applications. Oversees and resolves operational aspects of clinical trials in conjunction with project teams following standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations,...

Clinical Research Associate (CRA), Oncology, As a Field Based Clinical Research Associate , you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. In this role as an Oncology CRA , you will have the local responsibility for the delivery of the studies at allocated centers and are active participants in the local study team(s). You’ll work in close collaboration with other Monitors and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You will also be responsible for...

Clinical Research Associate (CRA), Oncology, As a Field Based Clinical Research Associate , you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. In this role as an Oncology CRA , you will have the local responsibility for the delivery of the studies at allocated centers and are active participants in the local study team(s). You’ll work in close collaboration with other Monitors and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You will also be responsible for...

Clinical Research Associate (CRA), Oncology, As a Field Based Clinical Research Associate , you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. In this role as an Oncology CRA , you will have the local responsibility for the delivery of the studies at allocated centers and are active participants in the local study team(s). You’ll work in close collaboration with other Monitors and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You will also be responsible for...

Clinical Research Associate (CRA), Oncology, As a Field Based Clinical Research Associate , you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. In this role as an Oncology CRA , you will have the local responsibility for the delivery of the studies at allocated centers and are active participants in the local study team(s). You’ll work in close collaboration with other Monitors and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You will also be responsible for...

Your skills could be critical in helping our teams accelerate progress. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology, and to incorporate new methodologies and pro-actively progress study execution. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can...

Your skills could be critical in helping our teams accelerate progress. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology in Gastroenterology, incorporate new methodologies and pro-actively progress study execution. We are an innovative global healthcare company with one purpose to chase the miracles of science to improve people’s lives. We’re also a company where you can...

Twist Bioscience is looking for a seasoned, team-oriented, Shipping Coordinator. This position will play a critical role in forming a best in class Shipping/Order Fulfillment team. This position will require collaboration with Manufacturing, Customer Support, and Supply Chain teams to ensure internal and external customer satisfaction. The Shipping Coordinator will perform all physical and administrative required for this position. This will include inventory management, continuous improvement, shipping, receiving, storing, distributing of orders, materials, parts, supplies and equipment. Must possess a team and collaborative attitude. Responsibilities Order fulfillment Perform inventory audit, reconciliation and inspection of finished goods and raw material.. Monitor,...

Position As the Associate Director of Trial Master File Operations, you will be responsible for leading the TMF (Trial Master File) operations function for clinical trials across Eikon Therapeutics. This is a senior-level position that requires a strategic thinker with the ability to drive change and improve processes. The successful candidate will be a strong leader with excellent communication and collaboration skills, and experience in managing TMFs for clinical trials. You will be accountable for ensuring the completeness, accuracy, and regulatory compliance of TMFs, and overseeing all TMF-related activities across the clinical trial portfolio. This role will require a...

Position We are seeking a seasoned physician with a strong clinical background and a passion for drug development to join our Clinical Development team to serve as a Study Responsible Physician as a Senior Director, Clinical Research, Oncology. In this role, you will play a pivotal part in advancing our Oncology pipeline by providing medical expertise, strategic leadership, and operational oversight for multiple clinical development studies. About You You are a highly accomplished professional who excels in the development and execution of clinical projects. As a key member of the cross-functional Development Teams and the Clinical Study Teams, you will...

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. The Clinical Account Coordinator role prioritizes customer service and entails cultivating and sustaining relationships with physicians and clinical staff to guarantee a superior Tempus experience. This position may necessitate travel between multiple accounts within a 20-mile radius or full-time dedication to a single account. The role requires phlebotomy...

Our location in Maple Grove, MN currently has an on-site opportunity for a Senior Clinical Quality Coordinator . This new team member will work independently, provide clinical quality team support to ensure compliance with applicable regulatory standards and Abbott Standard Operating Procedures. Additionally, independently manage document control change orders and provide clinical training (LMS) support and system training. What You’ll Work On Windchill Global Clinical Lead Librarian - Provide onsite and remote support to Global Clinical Affairs Organization (GCAO) within the Global Clinical Library. Includes requesting the appropriate access and providing librarian support. Initiate and manage IT intake requests for...

Clinical Associate In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Clinical Laboratory Scientist II is responsible for performing moderate and high complexity laboratory testing on patient specimens, interpreting and reporting patient results, performing quality control and quality assurance procedures, assisting Senior Scientists with advanced laboratory duties, and...

Are you a night owl looking for an impactful manufacturing opportunity? Join our dynamic team in Danvers, MA, as a Production Coordinator III in the Extrusion department, where you will play a vital role in coordinating and optimizing production activities during the 3rd shift. This position offers the chance to manage production schedules, ensure material availability, and collaborate with team leaders, supervisors, and planners within a highly regulated medical manufacturing environment. With your extensive knowledge and experience, you will help achieve production goals, ensure cost efficiency, and maintain high standards of quality and safety. If you are passionate about continuous...

This role is based in Tempe, AZ. It is NOT open to remote work. Careers that Change Lives The Sr. Inventory Coordinator role is an on-site/office position that is responsible for managing the Spinal inventory dedicated to the specified sales area. This position will be responsible for tracking inventory and logistically securing the inventory for spine cases at hospitals and surgery centers in the local area surrounding the office. The Sr. Inventory Coordinator works closely with local sales managers and sales reps in managing the assigned inventory and ensuring top utilization of the systems. This role acts as an “air...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. DPEM - Printed Packaging Material Coordinator The Drug Product External Manufacturing...

Clinical Associate In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises...

The Associate Principal Scientist is a DVM/VMD and/or PhD whose primary function is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires the candidate be responsible for the conduct of Good Clinical Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies. The Associate Principal Scientist is the primary clinical study team leader and has overall responsibility for a study. The Associate Principal Scientist can also be responsible for several effectiveness studies within a project, participating as the clinical representative in project...

Senior Director, Precision Medicine Therapeutic Area Lead – Cardio/Metabolic What you will do In this vital role, you will act in conjunction with the General Medicine/Cardiometabolic Therapeutic Area Head to drive the development and execution of Precision Medicine objectives. As the Precision Medicine Therapeutic Area Lead, you will guide the strategic vision, execution, and integration of translational and precision medicine strategies across asset and above-asset programs throughout the product lifecycle. You will Lead cross-functional teams to develop and implement phase-appropriate, integrated biomarker and human data strategies to support translational pharmacology and inform patient stratification/selection. Develop, lead, and serve as...

Clinical Research Associate (CRA), Oncology, As a Field Based Clinical Research Associate , you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. In this role as an Oncology CRA , you will have the local responsibility for the delivery of the studies at allocated centers and are active participants in the local study team(s). You’ll work in close collaboration with other Monitors and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You will also be responsible for...

The Scientific Engagement Project Coordinator will be a new role and provide both administrative, project management and communications support for the The Scientific Engagement Project Coordinator is a new role that will provide administrative, project management and communications support for the Biomedical Research’s global Scientific Engagement team, with specific emphasis on the planning, coordination and execution of programs and events to support organizational connectivity across Novartis global research organization. In particular, they will play a critical role in supporting Cambridge-wide programming and activities to further advancement of scientific understanding across the research organization. The candidate will also play an essential...

This role will serve as a leader for the Research Operations Clinical Trial Support function and is responsible for planning, implementation, execution, and oversight of specialty clinical lab testing (conducted internally and externally) in partnership with subject matter experts from Translational Biology, Immunology, and Genomics. The individual will also oversee and/or provide input on vendor selection and contracting, sample management and reconciliation, clinical site training, and site feasibility. The position will work cross-functionally with Clinical Operations, Project Management, Compliance, Data Management and other teams supporting clinical trial execution. The Opportunity to Make a Difference Provide comprehensive oversight of specialty lab...

Job Title Global Therapy Development Specialist We currently have an opportunity available for a Global Therapy Development Specialist to join our Vascular division. This is a fully Remote MAIN PURPOSE OF ROLE The Global Therapy Development Specialist champions issues that provide major implications for the company and may lead to accomplishing long-range objectives for US and OUS geographical areas. Provides broad, technical advice. Mentors sales trainers, marketing, and field sales personnel by sharing clinical and technical expertise and providing feedback and guidance. Acts as an advisor to management on specialized business projects (managerial, technical, leadership, clinical, training). Acts as...

AbbVie Precision Medicine Pathology organization is committed to driving tissue based translational and biomarker efforts for our pre-clinical and clinical stage programs. We are seeking a highly motivated ML/AI scientist to join our expanding computational pathology group to revolutionize digital pathology and precision medicine. Candidates for this senior position should have several years of experience in the field, a passion for research, and a track record of productivity and accomplishments. They should enjoy working in a fast-paced, dynamic and highly interactive environment. Their scientific leadership will enable them to independently and expertly guide teams in their approaches to quantitative image...

The Intake Coordinator I – Oncology acts on behalf of Caris as the first touch point for all oncology clients’ requests for molecular testing. Responsible for the creation of electronic orders utilizing the Caris laboratory information system, and the initiation of the specimen acquisition process. This position plays a crucial role in ensuring a timely and efficient process of procuring material for the Caris laboratory. Intake Coordinators respond to internal and external inquiries, and other support needs, and analyze all inbound supplemental documentation for existing patient cases awaiting missing information for case activation. Considerable independent judgment is required to carry...

The Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. Our company's Atherosclerosis & Metabolism medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage clinical development and studies, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. Specifically, the Senior Director May Be Responsible For Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New...

The Director (Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. Our company's Atherosclerosis & Metabolism medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development for late-stage studies, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. Specifically, The Director May Be Responsible For Planning clinical trials (design, operational plans, settings) based on these clinical development strategies Monitoring and managing the conduct of ongoing or new clinical...

The Senior CoreValve Therapy Development Specialist provides technical, clinical, educational and sales support to ensure safe adoption and growth of the Medtronic CoreValve System and future catheter-based therapy technologies. The CoreValve Therapy Development Specialist works closely with implanting teams and the Medtronic Catheter-based Therapies (CBT) and CVG field organizations to drive procedural and practice success. Technical and Clinical Support Provide clinical expertise for TAVR implanting centers, including “scrubbing in” for TAVI implant procedures to assist with loading valves onto delivery catheter, and providing technical support in accordance with the instructions for use/trial protocol, and best-practices to facilitate procedural consistency and...

The Clinical Laboratory Operations Leader is responsible for leading and facilitating the operations of a cGMP Clinical Laboratory. This role ensures that all safety, regulatory, and procedural requirements are met, while overseeing the production quality of clinical supplies. The Leader ensures compliance with build protocols and maintenance of lab equipment and materials. Additionally, the Leader supports activities in the Process Development Lab when the Clinical Lab is idle. Supervisory Responsibility Supervise the work/activities within the Clinical Lab through matrix management. No direct reports. Key Duties and Responsibilities People Responsible for the effective deployment of team members and the delegation of...

Position As a Clinical Trials Associate in Oncology, you will play a crucial role in supporting the planning, coordination, and execution of Phase I-III insourced global clinical studies within the oncology portfolio. Operating in a dynamic and collaborative environment, you will provide essential support for the execution of clinical trials, contributing to the development of groundbreaking therapies with the potential to transform patient lives. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ), New York City (NYC) or Millbrae (CA) offices to...

Clinical Associate In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises...

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to Career development with an international company where you can grow the career you dream of . Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings...

Clinical Associate In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises...

Careers that Change Lives The Sr. Clinical Research Director, Cardiac Ablations Solutions (CAS) reports directly to the Chief Medical Officer, CAS. This position is responsible for directing all global clinical research activities and programs to generate clinical and economic evidence in support of the business. The Clinical Research Leader is responsible for developing the clinical strategy in alignment with the business and R&D strategies for the Cardiac Ablation Solutions Operating Unit. The leader is also responsible for designing and driving the execution of pre-market and post-market clinical trials globally, including driving outcomes and results, and collaborating for the dissemination of...

This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. As a Coordinator Project Design, you will have the opportunity to provide organizational and project support to the department by working directly with a cross-functional teams, external translation suppliers, as well as internal Design Production Artists to coordinate and execute activities related to the development of packaging and labeling...

Clinical Associate In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises...

Clinical Associate In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises...

Make a difference in patients' lives by applying your diagnostic and clinical test market expertise as a Precision Medicine Liaison! Key responsibilities include ensuring the timely, high quality in-market companion diagnostics / testing solutions are available to support optimal treatment. Engage collaborators before and after launch to provide approved information to proactively address barriers to testing at pre-specified region reference labs, pathology medical groups and a subset of academic/health system with well-developed diagnostic and molecular capabilities within assigned geography. Act as the regional expert to support oncology customers at the request of the cross functional team by providing more in-depth...

Make a difference in patients' lives by applying your diagnostic and clinical test market expertise as a Precision Medicine Liaison! Key responsibilities include ensuring the timely, high quality in-market companion diagnostics / testing solutions are available to support optimal treatment. Engage collaborators before and after launch to provide approved information to proactively address barriers to testing at pre-specified region reference labs, pathology medical groups and a subset of academic/health system with well-developed diagnostic and molecular capabilities within assigned geography. Act as the regional expert to support oncology customers at the request of the cross functional team by providing more in-depth...

Clinical Associate In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises...

Please note that starting April 2025, Eikon Hayward positions will be moving to our new headquarters in Millbrae, CA Position We are seeking a detail-oriented and highly motivated Clinical Trials Associate (Contractor) to join our oncology research team. As a Clinical Trials Associate (Contractor) in Oncology, you will play a crucial role in supporting the planning, coordination, and execution of clinical trials within the oncology portfolio. The expected duration of this position is 9 months. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey...

We are looking for a Clinical Lab Associate who will be responsible for Sample Returns and Sendouts. Duties and Responsibilities Facilitate efficient specimen return and send-outs to custodian pathology laboratories and Tempus partners Monitor high-priority requests and audits to ensure customer retention and satisfaction Sort, file, and maintain long-term FFPE specimen storage Develop a firm understanding of lab processes and databases Ensure all sample return documentation is professional, accurate, and HIPAA-compliant Engage in timely issue reporting and resolution Build and maintain effective relationships with other laboratory employees Preferred Qualifications Bachelor's Degree Highly organized and systematic, superb attention to detail and...

POSITION OVERVIEW Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products. You will manage a geographical region(s) of assigned clinical studies or multiple components of larger studies. You will typically manage Phase I studies or other smaller studies. You will define and incorporate study logistics and study plans...

Position Overview The Material Coordinator 2 is responsible for picking, packing, and transacting inventory to support San Diego’s shipments. Order Fulfillment is responsible for various types of requests. This role will also be working with other departments within Distribution. Responsibilities Support picking, packing and shipping of material for order fulfillment by using scanners or by manual methods. Perform shipping functions under general supervision. Responsible for picking and packing all shipments from Illumina. Process orders using various ERP's UPS WorldShip, SAP, JIRA, and FedEx Ship Manager software. Establishes and maintains cooperative relationships within their team and any other departments contacted during...

The Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The Executive Director will manage and oversee the entire cycle of late stage clinical development from Phase 2 to Phase V, including development of program strategy and design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. They will lead cross-functional product development teams that oversee program strategy and execution, will provide internal scientific leadership for cross-functional areas supporting clinical...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. R-82730 Associate/Sr. Associate/Manager, Clinical Development Trial Lead (CDTL) The Clinical...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. The Associate Director, Clinical Development Trial Lead (CDTL) independently...

This position works out of our Easton Square location in the Nutrition Division. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Protality® and Glucerna®– to help get the nutrients they need to live their healthiest life. What You’ll Work On Consumer Relations acts as the Voice of Abbott Nutrition and a vital link to the marketplace. The department drives brand loyalty and delivers a quality experience...

This position works out of our Alameda, CA location in the Diabetes Care division where we're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. This position will provide clinical operational support to assigned clinical studies and projects. Interact with other departments and external suppliers and provide logistical support to clinical research teams. Perform responsibilities meeting project commitments and in compliance with applicable regulations, good clinical practice (GCP) and standards. Please note this is a...

Título do Trabalho Trainee Clinical Research Associate O Trainee Clinical Research Associate (Trainee CRA) deve adquirir competências e conhecimentos práticos na monitorização de ensaios clínicos através de formação em contexto de trabalho (on-the-job training) no Departamento de Ensaios Clínicos (GCTO-Portugal), nas seguintes áreas Gestão de protocolos e centros de ensaio clínico, apoiando e sob-supervisão de Clinical Research Associates, atividades de monitorização on-site e remotas, incluindo visitas de validação, iniciação, ongoing e close-out. Assegurar a conformidade com as Boas Práticas Clínicas (ICH-GCP), procedimentos, leis e regulamentos locais, bem como o protocolo do ensaio, plano de monitorização e documentos relacionados. ...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. In 1992, Eli Lilly and Company established the Delivery Device business...

Make a difference in patients' lives by applying your diagnostic and clinical test market expertise as a Precision Medicine Liaison! Key responsibilities include ensuring the timely, high quality in-market companion diagnostics / testing solutions are available to support optimal treatment. Engage collaborators before and after launch to provide approved information to proactively address barriers to testing at pre-specified region reference labs, pathology medical groups and a subset of academic/health system with well-developed diagnostic and molecular capabilities within assigned geography. Act as the regional expert to support oncology customers at the request of the cross functional team by providing more in-depth...

Director, Clinical Research Our business purpose is to lead and shape the treatment of patients with structural heart disease via driving innovation, prioritizing clinical research, and championing product and procedural excellence. What You’ll Work On The Director of Clinical Programs will lead the portfolio of clinical trials including clinical trial strategy development and execution to support evidence generation for Abbott’s transcatheter mitral and tricuspid interventions (TMTI) portfolio. The individual will interact with multiple internal cross-functional teams, including R&D, medical affairs, regulatory affairs and finance to set the overall direction for the TMTI portfolio, and create/manage budgets, priorities and timelines. The...

Legend Biotech is seeking a Clinical Trial Landscape Intern as part of the Translational team based in Somerset, NJ. Role Overview Cell therapies present an entirely new paradigm in drug development. Over 5000 oncology programs and greater than 900 non-oncology cell therapy programs are under therapeutic development. On-going clinical trial and early clinical trial results are crucial to understand the complex landscape. Early-stage Drug Development department is seeking a highly motivated and enthusiastic intern to assist our team in understanding the cell therapy clinical trials and researching the broader therapy landscape. The intern will have the opportunity to work closely...

Medtronic is hiring at our Memphis Airways Distribution Center, where our employees are helping us deliver on the extraordinary. We require fresh ideas and inclusive insights to maintain our position as an innovative industry leader. That’s why we actively seek, attract, and develop employees who are patient-centric, passionate, and who reflect the wide variety of life experiences found among our patients. We’ve been on a journey to modernize our U.S. distribution network and transform how we distribute our products. We’re aiming to elevate the customer experience and generate cost savings with state-of-the-art technology and standardized processes. But none of it...

Medtronic is hiring at our Memphis Airways Distribution Center, where our employees are helping us deliver on the extraordinary. We require fresh ideas and inclusive insights to maintain our position as an innovative industry leader. That’s why we actively seek, attract, and develop employees who are patient-centric, passionate, and who reflect the wide variety of life experiences found among our patients. We’ve been on a journey to modernize our U.S. distribution network and transform how we distribute our products. We’re aiming to elevate the customer experience and generate cost savings with state-of-the-art technology and standardized processes. But none of it...

Clinical Research Associate As a Field Based Clinical Research Associate, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. In this role, you will have the local responsibility for the delivery of the studies at allocated centers and are active participants in the local study team(s). You’ll work in close collaboration with other Monitors and the Local Study Delivery Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. You will also be responsible for the preparation, initiation, monitoring and closure of an...

Introduction to role As the Administrative Coordinator, you will support the Respiratory & Immunology - Insights, Analytics & Forecasting functional leaders and their senior staff while coordinating various projects. This includes prioritizing email correspondence, managing calendars, coordinating meetings, scheduling travel, and handling routine reporting. You will assist teams across Wilmington, Gaithersburg, Mississauga Canada, Barcelona Spain, and Cambridge UK by tracking projects, timelines, metrics, and generating requisitions and Purchase Orders (POs) via Coupa. Accountabilities Provide administrative services to the senior team, coordinating complex meetings and off-site events, diary arrangements, and travel in line with AZ policy. Process travel and expense...

The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of practical technical, mechanical and planning responsibility. The Equipment Development and Facility Engineering (EDFE) Mechanical Coordinator position will report to the Associate Director, Engineering and will be a member of the MACS EF Team at the Rahway, NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure. EDFE's role within...

Clinical Associate In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises...

The Clinical Trial Co-op will report into the Clinical Operations Program Lead (COPL), Immunoassay, Clinical Program Strategy and is responsible for the assessment, development, and improvement of clinical operational processes and supportive tools. As a co-op, you will gain valuable hands-on experience working alongside the Clinical Operations Program Lead on real-world projects, including process improvement initiatives, while learning about our clinical trial operating model. The Opportunity to Make a Difference This application is for a 6-month co-op program that will start on July 7th, 2025 , and conclude on December 19th, 2025 . This is a full-time, 40 hours a...

About the role The Round Lake Sr. Warehouse Coordinator performs scheduled activities for Shipping, Destruction, and Inventory Management in strict compliance with GMP, EHS, and Takeda Quality System. How you will contribute Supports all local Manufacturing Plasma Operations. Receives physical and electronic plasma shipments. Shipping and receiving bulk albumin, raw materials, and finished goods. Performs order status inquiries for all completed orders. Adjusts orders as necessary when damages or shortages occur. Help with the Staging of Disposition plasma to be delivered to production. Update department metrics. Coordinate with global logistics on scheduling international shipments. Create and manage open PO’s in...

2025 Fall Intern - Genentech Computational Sciences - Biology Research | AI Development, Machine Learning for Trial Design Department Summary We are seeking a highly skilled and motivated research intern to join the BRAID team (Biology Research | AI Development) within our Computational Sciences organization. At BRAID, we develop machine-learning methods for different applications in drug development. Within the clinical team in BRAID, we focus on building machine-learning methods to improve the design of early clinical trials. Fundamentally, we collaborate with clinical scientists, biologists, and engineers to design the next-generation clinical trials. The ideal candidate should have hands-on experience in...

Legend Biotech is seeking Purchasing Coordinator (Part-Time Contractor) as part of the Global MSAT team based in Somerset, NJ. Role Overview This position involves coordinating purchases from various vendors, ensuring timely order fulfillment, and maintaining accurate inventory records. The Purchasing Coordinator will collaborate with suppliers and internal stakeholders to optimize supply chain operations and provide insights for financial planning and budgeting. This position will require at least 20 hours per week. Key Responsibilities Coordinating the purchase of supplies from various vendors. Ordering, receiving and processing incoming orders for materials, merchandise, or services using SAP. Informing end users of order...

General Scope and Summary SAGE Therapeutics is seeking a highly skilled and experienced Medical Monitor Consultant to join our Clinical Development team. This consultant will provide critical medical oversight for ongoing and upcoming clinical trials, ensuring the safety and well-being of study participants, and will play a pivotal role in monitoring study data. The ideal candidate will have extensive experience in clinical trials, particularly in the areas of medical monitoring and clinical data interpretation. This role requires a detail-oriented, self-motivated professional with a strong clinical background and the ability to collaborate effectively with cross-functional teams, CROs, and external partners. Roles...

As an Senior Manager, Global Regulatory Affairs, Precision Medicine, you will help develop and execute Precision Medicine regulatory strategy in alignment with the drug global regulatory strategy and in compliance with the appropriate IVD regulations. You will need to work closely under the direction of the Precision Medicine Leadership, collaborate with the Biomarker diagnostics team and global/regional Regulatory liaisons, to support Precision Medicine global regulatory initiatives and offer guidance, as applicable. You will provide fit-for-purpose operational and technical diagnostics (Dx) regulatory assistance through all stages of drug clinical programs, global registration, and market access. This role will operate on a...

Careers That Change Lives We are currently looking for a highly motivated Senior Clinical Research Manager to join our Neurovascular Medical Science and Clinical Affairs group. The Neurovascular Operating Unit provides a comprehensive portfolio of proven, powerful neurovascular technologies, setting the highest standards of integrity and reliability in Acute Ischemic and Hemorrhagic Stroke Care. Click here to learn more about our Neurovascular Product Portfolio. This position can be based out of Irvine, California or Fridley, Minnesota. As Senior Clinical Research Manager you will be responsible for overseeing all clinical activities related to a portfolio of clinical studies. You will lead...

Quality Assurance Coordinator The QA Coordinator is responsible for general supervision of the manufacturing inspection and test functions at every stage of the manufacturing process. They may supervise inspection and test activities of operators. The perform function failure testing as well as physical defects testing. This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®,...

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker...

Help us change lives At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Lead Clinical Laboratory Scientist provides leadership support to the technical lab staff. This role is responsible for being the workflow and troubleshooting point person in the technical lab, coordinating and conducting day-to-day activities in the laboratory to...

PacBio has an exciting opportunity for a Manager, Technical Accounting and Audit/SOX Coordinator. PacBio (NASDAQ PACB) is a premier life science technology company that designs, develops and manufactures advanced sequencing solutions that enable scientists and clinical researchers to improve their understanding of the genome and ultimately, resolve genetically complex problems. Our mission is to enable the promise of genomics to better human health. Genomics is core to all biological processes, and our advanced genomics tools provide scientists and clinical researchers the insights to better understand biology and health. We are now entering the century of biology and genomics is at...

Legend Biotech is seeking a Batch Record & Document Coordinator as part of the Technical Operations team based in Raritan, NJ. Role Overview The Batch Record and Documentation Coordinator will work in a detail-oriented compliant manner coordinating the batch record flow, correction, proper and complete documentation. Key Responsibilities Communicating accurate and up-to-date status reviews to appropriate personnel and updating status tracking spreadsheets and preparing reports Assist in the correction of deficiencies found within the documentation reviewed per the cGMPs and SOPs on daily basis Ensure documents like batch records, labels, forms, etc. are printed and available for production...