Clinical Trial Site Lead: Start-Up & Oversight Expert

Immunocore; Radnor (Delaware County); On-site; USD 140,000 - 155,000; Full time

Job summary

Immunocore in Gaithersburg, MD / Radnor, PA area is seeking a Clinical Trial Manager to oversee site start-up and ongoing trial conduct across assigned assets. You will ensure adherence to protocol and regulatory requirements, coordinating with CPM, CROs, vendors and internal teams.

The role requires at least 5 years in clinical operations, strong GCP/ICH knowledge, and proven ability to build sponsor-site relationships.

Qualifications

• Minimum 5 years of clinical operations experience in biotech/pharma or CRO.
• Strong knowledge of GCP, ICH, GDP and CFRs; familiarity with MHRA/EMA guidelines is a plus.
• Experience with start-up and initiation of clinical trial sites.
• Proven ability to communicate and coordinate with internal teams, sites and vendors.
• Experience presenting high-level information orally and in writing.

Responsibilities

• Plan and manage Immunocore clinical trials in compliance with SOPs, ICH-GCP and CFRs.
• Oversee CROs and sites to meet recruitment targets and high-quality data.
• Track site visits, reports and protocol deviations; escalate issues.
• Conduct initiation visits and train sites on procedures.
• Collaborate with CPM and Medical Monitor to optimize start-up timelines.
• Support budgeting, IRB/EC submissions and essential document collection.
• Ensure consistency of clinical operations across trials and regions.
• Develop site feasibility, informed consent and monitoring plans.
• Deliver trial-specific training and monitor CRO performance.
• Lead patient recruitment and retention strategy efforts.

Job description

Immunocore in Gaithersburg, MD / Radnor, PA area is seeking a Clinical Trial Manager to oversee site start-up and ongoing trial conduct across assigned assets. You will ensure adherence to protocol and regulatory requirements, coordinating with CPM, CROs, vendors and internal teams.

The role requires at least 5 years in clinical operations, strong GCP/ICH knowledge, and proven ability to build sponsor-site relationships.