R&D Compliance Specialist
4 weeks ago
Job Summary:
The successful candidate will be responsible for developing, implementing, and maintaining sponsor oversight management systems, ensuring the quality of clinical research sponsored or co-sponsored by GSTT aligns with prevailing legislative and best practice requirements.
Main Responsibilities:
Develop and implement audit plans to ensure compliance with Good Manufacturing Practice, Good Laboratory Practice principles, and relevant regulations. Collaborate with QA and clinical trial management professionals to improve quality standards. Work autonomously and influence change to promote a quality research culture.
Key Skills and Qualifications:
Strong ability to build relationships, influence, and collaborate in a cross-functional team. Ability to communicate complex information effectively. Experience in monitoring and auditing clinical trials, risk management, and team leadership. Knowledge of research funding, approvals processes, and clinical trial regulations in the UK.
Person Specification:
Essential:
- Educated to at least degree level in a related subject area, e.g., life science or clinical subject
- Evidence of ICH GCP Audit and Monitoring Training
- Computer Systems Validation qualification
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