Clinical Operations Jobs in Pharma & Biotech

PRIMARY RESPONSIBILITIES Leverage multiple information sources, including LIMS, to review cases for accuracy and completeness of pathology tissue samples for Signatera and Altera testing. Interpret pathology reports, clinical notes and additional testing reports to complete light data entry for each tissue sample. Collaborate with team members to work to resolve potential discrepancies. Ensure that necessary notes and holds are placed on cases for non-conforming samples, discrepancies and/or missing information and escalated to ensure timely resolution. Confirm cancer types for the reporting team before the report is issued via emails and spreadsheet. Meet daily case metrics. Attend interdepartmental meetings. Provide...

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...

Logs shipments and receives samples in accordance with SOP and GLP compliance. Maintains shipment, receipt and condition records per SOP. Identifies and follows sample discrepancies through to resolution with site/vendor per SOP. Ensures timely transfer of samples to third party vendors or internal team for analysis. Ensures timely disposal of samples in accordance with SOP. Uses temperature monitoring system to ensure sample integrity is maintained during storage cycle. Coordinate sample receipt activities to ensure technicians are assigned to appropriately manage workload. Responsibilities Log shipments and receive samples for clinical and/or toxicology trials, in accordance with priority set by Bioanalysis team...

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. Purpose Through the application of scientific and medical training, clinical expertise,...

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards. The Senior Director has primary responsibility for the planning and directing clinical research activities involving new or marketed Neuroscience Medicines. Our company's Neuroscience Medicines span all phases of clinical development (pre-clinical to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development, including study...

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...

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...

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...

The CoreValve Senior Principal Therapy Development Specialist (TDS) 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 Expertise 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...

Clinical Trials Specialist will be supporting Phase I studies while playing a pivotal role in the successful execution of cutting-edge phase I clinical studies at Neurocrine! As a key player in the planning, conduct, and wrap-up of both domestic and global trials, you will be at the forefront of innovation in healthcare. From managing essential documents to ensuring adherence to Good Clinical Practice and maintaining impeccable documentation, you'll be making a meaningful impact on the future of medicine. Collaborate with top-tier professionals both internally and externally and be a driving force in promoting subject safety and data accuracy. _ Your...

The Director (Principal Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed Oncology medicines. Our company Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, the 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 plans, settings) based...

The Director (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 Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. Specifically, The 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 plans, settings) based on...

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 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 independent judgment in planning,...

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. Through the application of scientific and clinical training and expertise, the...

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. Organization Overview The Diabetes, Obesity & Complications Program Phase Clinical Research...

This Senior Clinical Scientist will be a key contributor in the clinical science activities of evidence generation for regulatory approval and/or engagement with physicians and payers, including protocol development, study implementation, data analysis, and reporting of results. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. Travel Expectation 20% Responsibilities...

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 General Supervisor, Clinical Laboratory directs the day-to-day laboratory operations, under the direction of the Director of Laboratory Operations (or designee); including, but not limited to, the general supervision and development of laboratory staff, assuring quality standards are...

Johnson & Johnson MedTech, Vision a member of Johnson & Johnson’s Family of Companies is recruiting for an Executive Administrative Coordinator within the U.S. Vision Care Organization to be in Jacksonville, FL. This position may require up to 10% travel (domestic and international). Per our J&J Flex Policy, the expectation for this position is to work in the Jacksonville, FL office 3-4 days per week and work from home 1-2 days per week. 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...

We are searching for the best talent for an Associate Director of Clinical Research located in Irvine, CA. Purpose This Associate Director Clinical Research will be leading a team of clinical research professionals to manage clinical trials and to develop evidence generation strategies (EGS) for multiple and/or complex projects within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization. Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will Is responsible for the delivery of assigned clinical programs through effective...

The primary function of the Clinical Research Associate (CRA) I position is to assist with clinical study operations as well as monitor clinical field and laboratory studies that will support the regulatory approval of new companion animal and livestock products. These studies will be conducted in compliance with the requirements of Good Clinical Practice (GCP). The Clinical Research Associate I acts as a point of contact with investigators and study site personnel, as well as manages all administrative aspects of a clinical study. The CRA, in collaboration with the Clinical Study Team Leader (CSTL) and other CRAs, may assist with...

We are looking for a seasoned and dynamic Executive Administrative Assistant to provide administrative and project support the Vice President of West/Mexico Region Global Manufacturing and Orange County Manufacturing leadership team. This role sits onsite 100% at our OC Campus. We offer you a position where you’ll be responsible for Management of calendars and scheduling Coordinate Quarterly and Functional Review calendar Consolidate Monthly Operations Review (MOR) reporting Travel planning Expense reporting Lead planning and execution for meetings on Medtronic sites or at offsite locations including catering arrangements and room set up coordination through facilities team Schedule audio conferences, video conferences,...

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 a Clinical Trial Assistant to be located in Spring House, PA. Purpose The Clinical Trial Assistant supports the Local Trial Manager (LTM) and/or Site Manager (SM) to ensure optimal management of...

The Trainer Timecard Administrative Coordinator works out of our Livermore, California location in the Heart Failure Division. In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. This role provides administrative support to the business in support of key objectives, milestones and timelines. WHAT YOU’LL DO Provide administrative support to business. Performs general administrative duties as assigned which may include coordination of travel arrangements, completing expense reports, telephone support, filing, and special projects. Collects, compiles, and analyzes complex data for management review...

About This Role The Associate Director Head of Clinical Trial Transparency (CTT) Operations leads and oversees all CTT activities, ensuring compliance with global regulations and Biogen policies for clinical trial registration and results disclosure. This role manages CTT resources, driving the function's performance and results. Key goals include aligning public information needs, regulatory requirements, and industry commitments across the portfolio, and maintaining audit and inspection readiness. The Head of CTT Operations also acts as the business unit representative for the CTT vendor, overseeing compliance, contract terms, process improvement, and budget. This position, which contributes to the functional strategy and reports...

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...

Associate Director, Clinical Research This position works out of our Plymouth or St Paul, MN location for our Electrophysiology Medical Device business. 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. This role will plan and manage multiple or complex Clinical Affairs Program(s) across all functional areas, within budget and timelines. Represents Clinical Affairs function at Clinical Advisory Board meetings, interactions with Regulatory Agencies, and for evaluation of business opportunities including due diligence. What You’ll Work On...

Our Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. The Senior Principal Scientist/Senior Director is responsible for protocol development and medical/scientific oversight of clinical research studies involving new or marketed drugs in the Vaccines Clinical Research group. He/she will be responsible for all phases of the trial process, including but not limited to the design, oversight and medical monitoring of Phase I to V clinical trials, preparation of progress reports...

As a Senior Clinical Trial Management PV Lead, you will play a pivotal role in ensuring the operational excellence and strategic oversight of safety processes, contents and data quality within clinical studies. Positioned within our pharmacovigilance team, this role is integral to maintaining compliance with global safety regulations while driving innovation in safety data review and management practices. From utilizing tools and processes for safety database configurations to leading quality reviews of Individual Case Safety Reports (ICSRs), you will be instrumental in shaping our clinical safety initiatives. Your expertise will support cross-functional collaborations, enhance safety data quality, and contribute to...

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 Senior Clinical Lab Associate, 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, exception handling, lab maintenance, and lab logistics. Tasks...

Medtronic Pelvic Health provides therapies that treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X™️ and InterStim™️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally and personally because of their condition. Our goal is to expand access to our therapies, and introduce new therapies, so we can potentially help millions of people get their lives back. As a Pelvic Health Therapy Development Specialist, you will play a critical role in the...

Medtronic Pelvic Health provides therapies that treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X™️ and InterStim™️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally and personally because of their condition. Our goal is to expand access to our therapies, and introduce new therapies, so we can potentially help millions of people get their lives back. As a Pelvic Health Therapy Development Specialist, you will play a critical role in the...

Medtronic Pelvic Health provides therapies that treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X™️ and InterStim™️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally and personally because of their condition. Our goal is to expand access to our therapies, and introduce new therapies, so we can potentially help millions of people get their lives back. As a Pelvic Health Therapy Development Specialist, you will play a critical role in the...

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 a Trial Supply Lead to be located in Titusville, NJ or Horsham, PA. Please note that this role is available across multiple countries and may be posted under different requisition numbers...

Senior Administrative Coordinator, V&I Location Gaithersburg, MD Introduction to role This is an exciting opportunity to take on a challenging and varied role within the Vaccines and Immune Therapies (V&I) unit. Your focus will be on providing high-quality professional administration support to the Senior Executives within V&I. As the successful role holder, you will be an individual with high standards, enthusiasm, and a passion for learning, together with excellent communication skills, a proactive approach, and the confidence to act independently. Attention to detail and having a high level of great organizational skills will be the key to success with this...

This position works out of our Plymouth, MN and Minnetonka, MN locations in the Electrophysiology Division. 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. The Calibration Coordinator performs various administrative tasks for the calibration department. Manage and maintain the calibration program This includes overseeing the scheduling, execution, and documentation of calibration activities for various types of equipment, such as torque tools, electronic equipment, force gages, pressure gages, dimensional equipment and various other inspection, measurement, and test equipment....

Medtronic Pelvic Health provides therapies that treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X™️ and InterStim™️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally and personally because of their condition. Our goal is to expand access to our therapies, and introduce new therapies, so we can potentially help millions of people get their lives back. As a Pelvic Health Therapy Development Specialist, you will play a critical role in the...

Medtronic Pelvic Health provides therapies that treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X™️ and InterStim™️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally and personally because of their condition. Our goal is to expand access to our therapies, and introduce new therapies, so we can potentially help millions of people get their lives back. As a Pelvic Health Therapy Development Specialist, you will play a critical role in the...

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We're focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Precision Medicine Field Director (PMFD) you will provide inspirational leadership and prioritize to drive high performance through your regional Precision Medicine Manager team. As a role model, coach and a liaison you will...

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...

Medtronic Pelvic Health provides therapies that treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X™️ and InterStim™️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally and personally because of their condition. Our goal is to expand access to our therapies, and introduce new therapies, so we can potentially help millions of people get their lives back. As a Pelvic Health Therapy Development Specialist, you will play a critical role in the...

Medtronic Pelvic Health provides therapies that treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with our sacral neuromodulation (SNM) systems InterStim X™️ and InterStim™️ Micro; and our percutaneous tibial neuromodulation (PTNM) system NURO™️. More than 400 million people worldwide have incontinence, and many of them limit their lives socially, professionally and personally because of their condition. Our goal is to expand access to our therapies, and introduce new therapies, so we can potentially help millions of people get their lives back. As a Pelvic Health Therapy Development Specialist, you will play a critical role in the...

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,...

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...

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. Organization Overview At Lilly, we serve an extraordinary purpose. We...

The CRA III 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 on-site in our Alameda, California location. What you will do 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. Participate in study start up activities. Responsible for shipping study devices and supplies to clinical sites and performing study device...