Champion compliance and precision-help deliver life-changing therapies.
Proclinical is seeking a GCP QA Consultant to support quality assurance activities for oncology-focused clinical trials. This role involves overseeing quality processes for phase 2-3 studies, ensuring compliance with ICH-GCP and regulatory requirements, and managing risk-based quality plans. You will collaborate with internal teams and external partners to maintain high standards of clinical trial execution and inspection readiness.
This is a fully remote position, open to candidates located anywhere within Europe.
Responsibilities:
1. Develop and oversee study quality-related plans, including Oversight Quality and Audit Plans.
2. Collaborate with third parties to formalize Investigator Site Audits (ISA) and agendas.
3. Oversee quality activities for phase 2-3 trials, focusing on risk management and endpoint de-risking.
4. Conduct risk-based reviews of study documents to ensure compliance with protocols, ICH-GCP, and regulatory requirements.
5. Act as the Clinical Quality Assurance Representative in weekly monitor-site meetings.
6. Monitor site performance, ensuring adherence to monitoring plans, tracking deviations, and recommending improvements.
7. Ensure internal operations align with study plans, SOPs, and maintain transparent communication regarding quality events.
8. Maintain and update Clinical Trial Oversight Plans and Clinical Quality Plans.
9. Ensure proper documentation and adherence to Clinical Trial Agreements, site feasibility, qualification, initiation, and activation processes.
10. Collaborate with TMF managers to ensure the Trial Master File (TMF) remains accurate and inspection ready.
11. Identify and address deviations, enforce corrective actions, and recommend process improvements.
12. Issue performance summary reports, define and measure KPIs, and escalate serious breaches when necessary.
13. Support change control requests related to clinical study materials or tools, providing quality input.
14. Develop and implement inspection readiness programs, supporting sites and staff during inspections.
15. Mentor and lead other Quality Assurance GCP Specialists.
16. Work with Regulatory Affairs on updated submissions or reporting requirements.
Key Skills and Requirements:
17. Strong knowledge of ICH-GCP guidelines and regulatory requirements.
18. Experience in quality assurance for clinical trials, particularly in phase 2-3 studies.
19. Proficiency in risk management and quality oversight processes.
20. Ability to manage and maintain TMF documentation and ensure inspection readiness.
21. Skilled in identifying deviations, implementing corrective actions, and driving process improvements.
22. Excellent communication and collaboration skills to work with cross-functional teams and external partners.
23. Familiarity with Clinical Trial Agreements, site feasibility, and activation processes.
24. Leadership and mentoring abilities to guide junior team members.