Clinical Trial Manager

Immunocore Ltd.; Maryland; Hybride; USD 140 000 - 155 000; Plein temps

Résumé du poste

Immunocore Ltd. in the United States (Gaithersburg, MD and Radnor, PA) seeks a Clinical Trial Manager to oversee site start-up and ongoing conduct.

You will ensure compliance with study protocols, ICH-GCP, and regulatory requirements while coordinating with the Immunocore Clinical Project Manager (CPM), CROs, vendors, and internal departments. The role emphasizes planning, site management, monitoring oversight, data quality, and timely execution across multiple trials.

Qualifications

• At least 5 years of relevant clinical operational experience in biotech/pharma and/or CRO.
• Working knowledge of GCP, ICH, GDP and CFRs; familiarity with MHRA/EMA/CHMP regulations is a plus.
• Experience with start-up and initiation of clinical trial sites.
• Experience creating and maintaining relationships with clinical trial sites and Principal Investigators.
• Ability to communicate and coordinate activities with internal teams, clinical sites and vendors.
• Ability to work independently with minimal supervision.
• Experience presenting high level presentations, both orally and in writing.

Responsabilités

• Participate in planning, implementation and management of Immunocore clinical trials in compliance with ICH-GCP and SOPs.
• Oversee CROs and clinical trial sites to meet recruitment targets and deliver high-quality data on time.
• Track site visit metrics, data quality concerns and protocol deviations.
• Conduct oversight site visits and pharmacy visits to ensure adherence to protocols and regulations.
• Assist at initiation visits to confirm site training and build sponsor-CRO-investigator-site relationships.
• Review CRA monitoring reports and ensure resolution of issues with CRO teams.

Connaissances

Clinical trial management

GCP & ICH knowledge

Site management

Vendor coordination

Regulatory submissions

Description du poste

## Job Details: Clinical Trial ManagerFull details of the job.| | || --- | --- || | || | || --- | --- || | Clinical Trial Manager || | VN903 || | Full Time || | Gaithersburg, MD, Radnor, PA || | Clinical Operations || | The Clinical Trial Manager will be responsible for managing clinical trial sites from study start-up throughout the course of the clinical trials until site close out. They will work to oversee that all aspects of the conduct of the trial sites and or across their assigned assets are in compliance with the study protocol, study operation plans, ICH current GCPs, and regulatory requirements. They will work collaboratively with the Immunocore Clinical Project Manager (CPM), Clinical Research Organization (CRO) representative(s), vendors and other Immunocore functional departments (as required) to drive start-up and ongoing oversight of clinical studies. Key Responsibilities: • Participate in the planning, implementation and management of Immunocore clinical trials/assets in compliance with industry regulations, ICH-GCP and applicable Immunocore controlled documents. • Oversee the site management of CROs and clinical trial sites to ensure delivery, per scope of work or contractual agreements, meet recruitment targets and deliver high quality data on time. • Track site visit and trip report metrics; data quality concerns and site level trending of protocol deviations. • Conduct oversight site visits including pharmacy visits, as required, to evaluate site and CRA performance and ensure adherence to study protocols, study operation plans, ICH GCP and regulatory requirements • Attend and assist, as required, at Initiation visits to confirm site training of therapeutic indication(s) and associated study procedures (e.g. Pharmacy training) and help build and foster sponsor-CRO-Investigator - site relationships • Review a percentage of CRA monitoring trip reports, ensuring oversight of CRO CRA and Site compliance with protocol, study plans, SOPs and ICH and GCPs, escalate identified report issues and ensure CRO study team resolve identified concerns • Collaborate with Immunocore CPM and Immunocore Medical Monitor for country and site identification, feasibility and selection to optimize processes to ensure efficient start-up timelines are met. • Support study start up in collaboration with internal and external project teams (e.g. Immunocore Project Manager, Regulatory, Clinical Supplies, Third Party Vendors, CRO) to ensure start up timelines are clearly defined and implemented, working to identify any risks and resolving any issues. • Act as subject matter expert for assigned protocols for study related issues, protocol and clinical operational queries arising from CRO, IRB/IECs/RAs, Third Party Vendors and sites. • Support the CRO/clinical trial site during start-up activities including, but not limited to, budget and contract negotiations, IRB/EC submissions and response and facilitation of essential document collection • Support Immunocore CPM to ensure consistency of Clinical Operations processes across clinical trials and regions, identifying areas where trial specific or regional differences are appropriate. • Contribute to the development and/or participate in the review of study related documents including (but not limited to) site feasibility, informed consent documents (site specific), monitoring plans, regulatory and start-up plans, patient recruitment plans, pharmacy and lab manuals and training materials • Execute and/or deliver trial specific training as required • Review of open action items and data trends; working with CROs to escalate and resolve identified issues to ensure standards for monitoring and reporting are met as well as to ensure better efficiencies and execution of our studies. • Contribute to the development of and oversee implementation of patient recruitment and retention strategies and acts on any deviations from plan. Education, Experience and Knowledge: Essential Qualifications: • At least 5 years of relevant clinical operational experience in a biotechnology/ pharmaceutical company, and/or CRO • Working knowledge of GCP, ICH, GDP and relevant CFRs is required; familiarity with MHRA/EMA/CHMP regulations and guidelines and other international regulatory requirements is a plus • Experience with start-up and initiation of clinical trial sites • Experience creating and maintaining healthy and creative relationships with clinical trial sites and Principal Investigators, helping to support and influence where required • Ability to communicate and coordinate activities with the internal team, clinical sites and vendors • Ability to work independently with minimal supervision • Experience presenting high level presentations, both orally and in writing Non-Essential Qualifications: • Knowledge of and experience with immunotherapies and/or Oncology • At least 2 years of on-site monitoring experience US Salary Range $140,000-$155,000 || | Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions. Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases. At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one another in these pursuits. Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law. |