Senior Clinical Trials Manager: Start-Up to Closeout

BioSpace; Radnor (Delaware County); Sur place; USD 140 000 - 155 000; Plein temps

Résumé du poste

Immunocore is seeking a Clinical Trial Manager to oversee site management from start-up through close-out across multiple projects. You will ensure compliance with GCP, ICH, and regulatory requirements while coordinating with CPM, CROs, vendors, and internal teams.

You will drive site qualification, monitoring oversight, and timely data delivery, with a focus on improving startup timelines and patient recruitment strategies.

Qualifications

• At least 5 years of relevant clinical operational experience in biotechnology/pharmaceuticals or CRO.
• GCP/ICH/GDP knowledge; familiarity with MHRA/EMA/CHMP regulations is a plus.
• Experience with start-up and initiation of clinical trial sites.
• Ability to build relationships with trial sites and investigators.
• Strong communication and independent working skills.
• Experience presenting complex information in writing and orally.

Responsabilités

• The Clinical Trial Manager will manage clinical trial sites from start-up to close-out and ensure compliance with the protocol and regulatory requirements.
• Oversee CROs and site performance to meet recruitment targets and deliver high-quality data on time.
• Track site visit metrics, data quality, and protocol deviations; address issues.
• Conduct oversight visits including pharmacy visits to evaluate site performance and adherence to ICH GCP.
• Support initiation visits to confirm site training and sponsor-CRO-Investigator-site relationships.
• Review CRA monitoring reports to ensure CRO and site compliance with SOPs and plan timelines.
• Collaborate with CPM and Medical Monitor for country/site feasibility and selection to optimize start-up timelines.
• Support start-up activities with internal/external teams to define timelines and resolve issues.
• Act as SME for assigned protocols for trial-related operational queries.
• Support budget/IRB submissions and essential document collection during start-up.
• Contribute to standardization of Clinical Operations processes across trials and regions.
• Contribute to development and oversight of patient recruitment and retention strategies.

Connaissances

Clinical operations

Regulatory compliance

Communication

Independent work

Description du poste

Immunocore is seeking a Clinical Trial Manager to oversee site management from start-up through close-out across multiple projects. You will ensure compliance with GCP, ICH, and regulatory requirements while coordinating with CPM, CROs, vendors, and internal teams.

You will drive site qualification, monitoring oversight, and timely data delivery, with a focus on improving startup timelines and patient recruitment strategies.