Clinical Operations Jobs in Pharma & Biotech

This Production Coordinator III will work under general supervision to perform diversified duties such as implementing product Bill of Materials (BOM) and manufacturing flow configurations in a Manufacturing Execution System (MES) to ensure that product traceability are accurately captured in MES to meet FDA compliance requirements. This Production Coordinator III will also maintain documentation of department policies and procedures and ensure compliance with FDA and Medtronic Quality Systems. During quality issues, the MES Coordinator may perform data mining to identify suspect materials and coordinates with production to contain suspect materials by executing Quality Holds in FACTORYworks. A Day in...

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...

The Obesity organization is seeking a Medical Director that will work with a team of physician-scientists that support evidence generation for obesity and obesity-related conditions. Responsibilities Provide clinical/scientific knowledge into the development, design, delivery, and communication of the global evidence generation plan for multiple metabolic assets. Be able to plan, provide input and guidance to clinical trials design and implementation Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program Participate and provide clinical input into safety and regulatory interactions Act as medical monitor during clinical trials execution. Interpret and communicate clinical trial...

Clinical Research Medical Director, Inflammation What you will do In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the indication(s). Provide oversight of LCM clinical development with input on global strategy Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access, and value input into the development program(s) Participate and provide clinical input into safety and regulatory interactions. Interpret and communicate clinical trial data. Author/review CSRs, publications, and regulatory submissions Develop key opinion leaders and make...

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at We are searching for the best talent for Lentivirus Batch Record Coordinator to be in Raritan, NJ. Purpose Contributes as an entry to developing individual contributor, who works under close supervision. Helps implement projects, programs, and processes in support...

The Senior Director (Senior Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed Oncology medicines. Our company's Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development, including study design, placement, 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 plan and Investigational New Drug applications. Developing of clinical development strategies for investigational or marketed Oncology drugs Planning clinical trials (design, operational...

Responsibilities may include the following and other duties may be assigned. Oversees, designs, plans, and develops clinical evaluation research studies independently with general supervision. Communicate and coordinate study activities between study sponsor, site research coordinators, study investigators, working closely with Clinical Research Manager and/or Project Coordinators Prepares with and authors protocols and patient record forms. Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer commercial potential. Oversees and interprets results of clinical investigations in preparation for new drug, device, or consumer application. Oversees and resolves operational aspects of clinical trials...

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 is responsible for performing standard laboratory procedures within the assigned department/laboratory. The Clinical Laboratory Technician will analyze data and may assist with research and development. This incumbent will be relied upon to follow laboratory...

The 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 best...

In this exciting role as a Senior Clinical Research Specialist (Sr. CRS) in our Surgical Operating Unit, you will have primary responsibility in the execution and oversight of global clinical studies. An individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. Most of the time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally...

The CRA II will assist in the clinical execution and management of all aspects of assigned clinical studies. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards. This position is located in Alameda, California. What you'll do The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Conduct single or multi-center medical device clinical studies. Perform study site visits (SQV, SIV, IMV, COV), generate monitoring trip reports, and track resolution of action items....

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. Job Summary Through the application of scientific training and clinical training...

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. Job Summary Through the application of scientific training and clinical training...

We are devoted to discovering and developing new medicines for those patients with unmet medical needs. AbbVie's clinical research operates with a collaborative model that seeks to build the pipeline of discoveries from inside and outside the company's own walls. AbbVie's current therapeutic areas of interest are Antiviral (HCV, HIV and RSV), Immunology, Men's Health, Neuroscience, Oncology, Pain, Renal, and Women’s Health. Within each of these therapeutic areas, we have various products in development. The products will change over time as compounds progress through our development program. A critical component of medicinal product development is clinical research, which involves conducting...

POSITION SUMMARY This Senior Manager, Clinical Trial is responsible for managing all aspects of clinical trials to support the development, validation, and commercialization non-invasive molecular diagnostic tests. This role manages clinical operations staff and all aspects of the trials independently, including study design, protocol implementation, site monitoring, and recruitment site management. PRIMARY RESPONSIBILITIES Responsible for the implementation of clinical trial activities per study protocol. Works closely with investigative site personnel, CROs, and other study vendors Manage and coach junior clinical research staff (e.g. CRA, CTA) Manage study contracting, budget and payment process for all clinical trial vendors including investigational...

This position will support territory needs between Chattanooga, TN; Knoxville, TN; and Rome, GA. 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...

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. Responsibilities may include the following and other duties may be assigned. Provides project...

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a...

Johnson & Johnson is hiring for a Principal Clinical Research Associate – Shockwave Medica l (Remote) to join our team. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Fueled by innovation at...

Johnson & Johnson Innovative Medicine is recruiting for an Executive Meeting Coordinator , located in Spring House, PA for the Immunology Therapeutic Area (TA) within Research & Development. This position will provide advanced administrative responsibilities and operational support to the Senior Director of Portfolio & Operations team and offers broad-based assistance to the team within the Immunology Therapeutic Area (TA). This role requires exceptional organizational, communication, and problem-solving skills, along with the ability to manage sensitive and confidential matters with discretion. Operating independently and with minimal supervision, the role ensures seamless coordination of executive calendars, priority meetings inclusive of the...

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Santa Clara, CA, currently has an opportunity for an "Advisor, Clinical Research" to join our ONSITE Clinical Science team This position will work closely within the clinical study team including the medical director, biostatistician, project management, data management, and other clinical study personnel. This position will have significant interaction with executive leadership, physicians and regulatory authorities. Furthermore, this position...

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 assigned clinical studies or multiple components of larger studies. You will manage Phase I Virology studies. You will define and incorporate study logistics and study plans to accomplish clinical study objectives. You may also participate in...

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...

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 Roche/Genentech Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late stage development (Phase 2-3) clinical strategies and plans to deliver medically differentiated therapies that provide meaningful improvement to patients. Alongside the Clinical Science Leader (CSL)/Global Development Leader (GDL), the Senior Clinical Scientist leads the development of the clinical science aspects of the Clinical Development Plan (CDP) strategy and supports various deliverables for effective and efficient CDP execution for the molecule/indication. The individual in this role will work very closely with colleagues to support late stage programs in the Obesity/Metabolic space. Senior...

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...

Director IVD Strategy & Operations - Precision Medicine Unit What you will do In this vital role you will work closely with the PMED Head of Strategy & Ops. and Head of CDx, as well as a number of cross-functional Dx stakeholders (Regulatory, Quality, Safety, Medical, Commercial, etc.) to advance the development and delivery of IVD/Dx strategies. You will serve as the lead and steward of a cross-functional team in charge of driving cross-functional decisions and alignment regarding Amgen’s position and strategy to align with global IVD regulations including IVDR in EU, new LDT regulations in US, etc. Additionally,...

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 Lab Associate I, Specimen Processing is responsible for performing the day-to-day operations of the Specimen Processing Department including, but not limited to, lab productivity and process line support, such as accessioning, processing, automation usage, sample racking,...

Seeking a highly organized, motivated and proactive individual to join our dynamic team. Reporting to the Director of Medical Science, the Project Coordinator III is responsible for providing administrative support, managing project and program activities, and facilitating smooth communication internally and with external stakeholders. The ideal candidate will have strong multitasking skills, excellent communication abilities, and a knack for problem-solving. Position Responsibilities; Performs the following tasks with limited supervision Manage calendars, schedule meetings, and coordinate logistics for teams Prepare and distribute meeting agendas, minutes, and follow-up action items Handle correspondence and communication with internal and external stakeholders Maintain organized filing...

The Clinical Research Associate will advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance. Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. This role will be assigned investigative sites in the Phoenix, AZ area. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience. Considered as the primary point of contact for the investigative site....

The Clinical Research Associate will advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry leading performance. Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. This role will be assigned investigative sites in the Chicago, IL area. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience. Considered as the primary point of contact for the investigative site....

Job Function Clinical Operations Sr Manager, Budgets & Contracts Level M4 The Senior Manager, Clinical Budgets & Contracts is responsible for strategic oversight and execution of clinical contract and budget operations. This role provides leadership to a team supporting clinical trial start-up and lifecycle management, ensuring timely, compliant, and cost-effective contracting with investigational sites and third party suppliers. This role leads a team responsible for an assigned functional stream (NDAs, Site Contracts / Budgets, Vendor Contracts / Budgets, Payments…) while partnering closely with study teams, Legal, Finance, and/or AP to drive process excellence and scale operations to meet...

We are searching for a Director, Precision Medicine Value and Access. The position will be based in Horsham, PA. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at It is imperative that J&J’s commercial model adapts to accommodate the nearly 50% of the anticipated precision medicine enabled assets launching in the...

Clinical Research Medical Sr. Director - Thoracic Oncology What you will do In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for small cell lung cancer (SCLC) indication(s). Additional responsibilities include Provide therapeutic area expertise in thoracic oncology and drive development, execution, and communication of the global scientific/medical evidence plan for small cell lung cancer area, including leading the evidence generation team. Serve as global development lead for specific small cell lung cancer indications and/or patient impact expansion (PIE) strategies. Integral contribution...

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...

The Sr. Clinical Research Director, Core Surgical Innovations (CSI) reports to the VP, Clinical Research & Medical Science, Surgical. This position is responsible for directing all global clinical research activities and programs to generate clinical evidence in support of the business. The Clinical Research Leader is responsible for developing the clinical strategy in alignment with the business, R&D and commercial strategies for the CSI Business 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 the resulting evidence to internal...

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. Associate Director– Clinical Trial Foundations Purpose The Associate Director, Clinical Trial...

About the job Your skills could be critical in helping our teams accelerate progress. Join our Fitusiran Clinical Team as Senior Clinical Research Director and you will be the primary Clinical Lead for Phase 3 registrational studies and on-going NDA submissions. Qfitlia (fitusiran) is a first-in-class AT lowering therapy approved by the US FDA for prophylactic treatment of adults and pediatric patients We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment,...

Twist Bioscience is looking for an individual that is highly motivated, collaborative, takes pride in their work, and great attention to detail. This position will play a critical role in forming a best in class Shipping/Order Fulfillment team. This position will require interactions with Manufacturing, Customer Support, Receiving, Warehouse, and Supply Chain teams to ensure internal and external customer satisfaction while ensuring all orders are processed and shipped in a timely and required manner. The Shipping Coordinator II will perform all administrative and physical requirements of this position. What You’ll Be Doing ●Pick & Pull products in accordance to the...

POSITION SUMMARY The Logistics Coordinator will support operational activities related to the inbound and outbound transport of biological specimens and collection kit manufactured products. Responsibilities will include tracking specimens from the point of pickup through delivery. Employees will act as a liaison between Customer and both external and internal partners. Job assignments should be managed without immediate supervision and evaluated based on performance. Individuals must be able to perform each essential core function as well as monitor and maintain the department service levels. All work is subject to additional requests as assigned by Department Manager. Coordinates and consolidates domestic...

POSITION SUMMARY The role of Patient Coordinator will be central to the success of the Prospera product line. This position will be focused on growing the relationship between Natera and its patients to ensure timely management of testing. Core responsibilities include collaborating with Nurse Coordinators to increase revenue and drive market development through direct sales by being the key contact for patient needs. The Patient Coordinator will accomplish this by being the patient advocate within Natera. *Spanish strongly preferred* PRIMARY RESPONSIBILITIES Work with assigned Nurse Coordinator to maintain & support existing customers. Assess the needs of patients with a...

Patent Coordinator - IP Litigation Administrative Coordinator What you will do In this vital role you will will provide administrative support to the Intellectual Property Litigation team. The successful candidate will provide support to the Intellectual Property Litigation team by assisting and supporting our litigation teams in the U.S. and global intellectual property litigations, including maintaining electronic databases. Candidate will also draft correspondence, e-mails, engagement letters with outside counsel; obtain references, case law, patents, file histories; organize materials, etc. The work assignments are sometimes complex in nature and require absolute discretion, as well as considerable tact, judgment, creativity, and...

We are searching for the best talent to join our Vision team as a Staff Clinical Research Scientist located in Jacksonville, FL Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for...