Clinical Operations Jobs in Pharma & Biotech

Purpose This position must have a functional knowledge of DEA regulations that pertain to USDO operations. Support processing controlled drug orders, including the use of DEA 222 order forms, and must meet DEA compliance requirements. Must develop an understanding of regulations pertaining to ARCOS reporting and be able to verify and correct monthly ARCOS reports. Will support export shipments and must have or gain working knowledge of US Customs, regulations, and importing and exporting shipments. Support USDO goals and responsibilities. Responsibilities Must be able to perform all responsibilities of DEA office coordinator position, prioritize responsibilities and work under general...

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 The Trial Capabilities Associate (TCA) provides clinical trial capabilities in...

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...

The Clinical Director (Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a focus on late-stage development, the Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Clinical Director May Be Responsible For Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications. Providing clinical development support of business development assessments of external opportunities to grow...

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to...

Our Abbott story is one of delivering bold solutions in the face of complex healthcare challenges. At Abbott Electrophysiology (EP), we’ve been a leader for over 20 years, pioneering one of the first mapping systems, introducing the first contact force ablation catheter and creating a portfolio of products trusted in millions of procedures around the world. We have and will continue to redefine what’s possible in an evolving and challenging EP landscape. When you join Abbott EP, you become part of a passionate group of individuals who are dedicated to driving the EP space forward and helping people live longer,...

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,...

In this exciting role as a Clinical research Specialist , you will have primary responsibility to manage day-to-day study operations within the Medtronic Clinical P hysiology L ab. This is a Research Specialist role reporting to the Clinical Lab Manager. The Clinical Research Specialist will independently develop and maintain clinical study documentation including developing clinical investigation plans, case report forms, IRB submissions, trail master files, SOPs and additional plans and documents as needed . The Clinical research Specialist will facilitate and maintain clinical study databases and assist with the drafting, distribution and tracking of study paperwork , and informed consents...

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. Overview/ The process of sourcing and supplying Investigational Medicinal Products and...

The Clinical Trial Manager (CTM) is accountable for end-to-end study operational oversight and delivery at country level, ensuring adherence to timelines, budget and quality standards. Acts as the primary point of contact at a country level for both internal and external stakeholders, ensuring clear communication, effective coordination, and successful project execution. Key Responsibilities Acts as the main point of contact for a country with global study team members and accountable for the coordination with local country cross functional teams. Implements the local country and site feasibility process, including proposal and validation of country study targets, as endorsed by country leadership....

The Precision Medicine - Medical Affairs Director - Health Systems Oncology (PM MAD-HSO) develops ongoing professional relationships with healthcare decision makers across Reference Laboratories, managed markets organizations, Integrated Delivery Networks (IDNs), Oncology Pathway Organizations, Oncology Group Purchasing Organizations (GPO), Medicare Administrative Contractors (MAC), and State Oncology/Hematology Societies. The PM MAD-HSO provides accurate information across the full oncology product portfolio, precision medicine, clinical science, and quality management in a balanced and credible manner consistent with the regulatory environment and the company’s ethical standards. This role also serves as a resource for the Medical Affairs (MA) management team on strategic planning and...

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 The Clinical Research Lead (CRL) is a strategic, field-based scientific...

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...

Provides administrative and operational support to ensure the smooth day-to-day functioning of the laboratory environment. Assists in coordinating equipment service requests, maintaining asset records, and supporting the execution of equipment service requests, calibration and maintenance activities. _ Your Contributions (include, but are not limited to) Assists in scheduling and tracking laboratory equipment repairs, maintenance and calibration activities. Helps to collect quotations, prepare purchase requests and coordinate vendor visits as needed. Maintain service logs, calibration certificates, and other related documentation to ensure compliance with internal and external standards. Supports record distribution and retention and data entry. Provide logistics support for internal...

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 II, Specimen Processing is responsible for performing the day-to-day operations of the Specimen Processing Department; including, but not limited to, lab productivity, process line support, exception handling, storage, maintenance, and logistics. Tasks may include...

We are one of the leading pharmaceutical companies in the world, dedicated to the discovery, development, and delivery of innovative medicines that improve health and quality of life for people. With a strong global presence and an unwavering commitment to scientific research, our mission is to transform health through innovation and excellence in healthcare. We value diversity and inclusion, fostering a collaborative work environment where all employees can contribute their ideas and talents. We believe that our strength lies in the people who are part of our team, and we are constantly looking for passionate and dedicated professionals who want...

Responsibilities may include the following and other duties may be assigned. Provides project or program support to a functional group or business process. Monitors program/project/system status, budgets and timetables. Applies knowledge of and experience in company operations to assist in the development, implementation and administration of program/system guidelines and procedures. Gathers and compiles information for reports. Provides technical support, which may include program/system training, program/system documentation, data extraction, data review, tracking and coding. Maintains Design History File and work in Product lifecycle management (PLM system) Serves as Change Analyst to route changes into PLM system. Must Have Minimum Requirements High...

We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role. 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...

POSITION SUMMARY Assists in analyzing specimens and maintains equipment in good operating condition. PRIMARY RESPONSIBILITIES Assist in testing of patient samples according to standard operating procedure. Meet expected performance metrics within role as applicable. Responsible for maintaining updated understanding and knowledge of methods performed in the lab Provide guidance for new team members. Follows GLP (good laboratory practice) maintain clean and organized workspace Completes training and other deadlines on time. Recognizes, escalates, and troubleshoot equipment malfunctions and common processing errors according to the laboratory’s standard operating procedures Recognizes, documents, and escalates...

Legal Coordinator What you will do We are seeking an Administrative Legal Coordinator to support attorneys and paralegals in the Corporate Litigation Group. The successful candidate will be highly organized, detail-oriented, flexible and able to multi-task. Responsibilities will include managing multiple and/or complex calendars; using good judgment and discretion in prioritizing schedules and maintaining confidentiality of information; coordinating meetings (often across multiple time zones); arranging travel and catering; processing expense reports; setting up engagement letters and tracking invoices; and maintaining case files and calendars. Additional miscellaneous tasks as needed including registration of visitors, activation of badges for site visits,...

Clinical Research Medical Director, Cardiometabolic What you will do In this vital role you will support the development, execution and communication of the global scientific/medical evidence plan. Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program. Support the development of key scientific external relationships with opinion leaders. Participate and providing clinical input into safety and regulatory interactions. Provide clinical/scientific input during the development and execution of clinical trials Interpret clinical trial data Participate in safety assessments Participate in interactions with regulatory agencies Author CSRs, publications and regulatory submissions Develop key opinion...

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 Genetic Testing Coordinator II is responsible for coordinating testing and communication between departments. The Genetic Testing Coordinator I will assist with the entire inventory of active tests throughout the testing process. Essential Duties Include, but are not...

Our lab is seeking an experienced administrative assistant with prior experience of working in an academic environment. We are looking for a people-oriented individual who, beyond working closely with the PI, will enjoy working with members of our lab (4-8 people) and with many other individuals in offices throughout Whitehead, MIT, HHMI as well as with scientists from other institutions. You will support Dr. Vale and research staff by providing analytical and specialized administrative support through administrative duties in areas such as lab supply ordering, travel, budget preparation and monitoring, event planning, grant and manuscript preparation, and special projects. What...

The Senior Travel Coordinator delivers exceptional travel management and customer service as part of HHMI’s on-site travel office. This role is responsible for coordinating all aspects of business travel, ensuring adherence to HHMI policies and a consistent, high-quality experience for travelers. The y will communicate effectively with clients, collaborate with internal teams to streamline operations, and use advanced booking tools to secure efficient and cost-effective travel solutions. Responsibilities include supporting conference and event travel logistics , managing hotel rooming and arrival lists, monitoring overflow properties, assisting with vendor analysis, and recommending process improvements. This position reports to the Travel Services...

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 Clinical 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. They 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 and...

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...

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. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. 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 Johnson & Johnson Innovative Medicine is...

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 Assoc III, Pre-Analytical 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 may...

We are seeking a committed professional to join our team. While this is a remote position not located at a physical Medtronic site, the candidate hired will be required to reside within the territory and drive to multiple accounts throughout the region. A valid driver's license is essential for this role. The CoreValve 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...

This position works out of our Sylmar, CA location in the CRM Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. Provides scientific expertise throughout the development and implementation of clinical studies, clinical evaluations, or risk management. Writes / manages clinical trial protocols, protocol amendments, clinical study project timelines, clinical evaluations (planning and reports), risk master lists, clinical trial registrations and results postings, and scientific publications. Interacts with various study support groups and cross-functional teams in order to...

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...

Neurocrine Biosciences is seeking a Sr. Talent Acquisition Coordinator in San Diego to play a pivotal role in our Talent Acquisition (TA) team. This is your chance to contribute to the full cycle recruiting process, enhance candidate experience, and ensure our recruiting systems and programs scale to meet our future growth. _ Your Contributions (include, but are not limited to) Coordinate and schedule complex interviews for candidates across various departments, ensuring timely communication and logistical arrangements Handle travel and expense reporting, and large-scale interview hubs Partner with recruiting teams, hiring managers, and business partners to streamline job requisition processes, approvals,...

We are searching for the best talent for a Senior Site Manager (CRA) to support MedTech business. Please note candidates must have access to an airport nearby due to the extensive travel requirements of the role . This is a remote role available in multiple states within the United States . While specific cities are listed in the Locations section for reference, please note they are examples only and do not limit your application. We invite candidates from various locations to apply and encourage you to review the following states where this opportunity is available Eastern US Broadly Alabama, Arkansas,...

The Senior Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Director May Be Responsible For Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications. Providing clinical development support of business development assessments of external opportunities...

In this exciting role as a Clinical Research Specialist, your day centers on preparing sites for data collection, ensuring data quality, and building strong relationships with research coordinators. You support clinical trials by maintaining regulatory compliance and assisting with various study tasks under the guidance of a Clinical Study Manager. Success in this role relies on attention to detail, effective communication, and problem-solving, all while prioritizing participant safety and smooth study progress. The Structural Heart and Aortic integrated operating unit offer minimally invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the...

About the role At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. The Senior Project Coordinator will provide support in two areas first is administrative assistance including, but not limited to, calendar management, expense reports, domestic and international travel arrangements, purchase orders, event planning, office supplies and other administrative support for the manager and leadership team in accordance with Company policies...

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 Medical Operations Coordinator III will interact closely with the Medical, Laboratory, and Clinical teams at Exact Sciences and will be responsible for coordination of day-to-day operational support for key aspects of various team meetings, reviews, and operational...

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 TAIP TA Lead is a senior leadership role reporting directly to the Head of the TAIP unit within Bristol Myers Squibb’s Trial Analytics, Insights, and Planning (TAIP) organization—an internal consulting team that drives clinical development excellence through data-driven insights, feasibility modelling, and strategic trial planning. As the analytics lead for a therapeutic area (TA), you will be responsible for the full portfolio of trials within that TA—owning analytics strategy, resource planning, and delivery oversight. You’ll provide strategic direction, hands-on support, and quality control across studies while coaching study-level analytics leads and coordinating cross-trial priorities. You will act as a...

The Shipping Coordinator performs the physical or administrative tasks involved in shipping, receiving, order fulfillment, storing and distributing of materials, parts, supplies and equipment, and supporting logistics areas. This may include receiving and verifying incoming materials and supplies, preparing bills of landing and shipping manifests, routing shipments appropriately, moving material within the warehouse, distribution and production facilities, filling customers’ orders and preparing orders appropriately. Primary roles and responsibilities include but not are limited to Preparation, QC, and shipment of finished goods according to SOP, assuring on-time and accurate shipments. Pack, ship, receive and maintain inventory of product/raw material, and fulfill...

The Associate Director, Precision Medicine Data and Analytics position will involve developing clinical biomarker analysis plans in collaboration with biomarker and diagnostic leads, as well as conducting data analysis to summarize and interpret clinical trial data. This position will be also responsible for integrating clinical development objectives with global considerations into strategic business decisions and advanced data analytics for assigned programs in portfolio. Key Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Oversee the analysis of complex biological data from clinical trials, ensuring robust interpretation...

We are looking for a motivated and detail-oriented Paralegal/Legal Coordinator to join our dynamic legal team. The successful candidate will support the Trademark Department with various administrative and project-oriented tasks. The ideal candidate is self-motivated, efficient, and a team player, with excellent organizational and accountability skills. Key Responsibilities Responsibilities for this position include, but are not limited to Perform a variety of complex project oriented, administrative matters and responsibilities on behalf of Trademark Department, both internally and externally. Support practice area on multiple day-to-day responsibilities and administrative tasks. Work independently and serve as a key team contributor for special...

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,...

The Clinical Trial Manager works out of our San Diego, CA office location in the Infectious Disease Division in Abbott Rapid Diagnostics. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. What You’ll Work On Serve as the clinical trial subject matter expert for rapid in vitro diagnostic studies, with a focus on 510(k) OTC and dual 510(k)/CLIA waiver submissions....

Our Abbott story is one of delivering bold solutions in the face of complex healthcare challenges. At Abbott Electrophysiology (EP), we’ve been a leader for over 20 years, pioneering one of the first mapping systems, introducing the first contact force ablation catheter and creating a portfolio of products trusted in millions of procedures around the world. We have and will continue to redefine what’s possible in an evolving and challenging EP landscape. When you join Abbott EP, you become part of a passionate group of individuals who are dedicated to driving the EP space forward and helping people live longer,...