Clinical Trial Manager: Start-Up & Site Oversight

Immunocore Ltd.; Maryland; Hybrid; USD 140,000 - 155,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Clinical trial management

GCP & ICH knowledge

Site management

Vendor coordination

Regulatory submissions

Job description

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.