GCP Compliance Manager
4 weeks ago
Trova Talent is seeking a highly skilled GCP Compliance Manager to join our team. As a key member of our organization, you will be responsible for providing compliance oversight and ensuring the highest standards of quality in our clinical trials.
Key Responsibilities:
- Develop and implement systems to advance GCP compliance within the organization
- Provide strategic support to clinical study teams and establish measures to reduce compliance risks
- Collaborate with Quality Assurance, Regulatory Affairs, and the Clinical team to develop internal policies and standard operating procedures
- Manage eTMF implementation, maintenance, and training activities
- Ensure qualification of GCP vendors and manage the GCP audit calendar
- Perform TMF compliance checks and support Inspection Readiness activities
- Assist in Trial-Specific Training and assess/ensure proper documentation of Clinical Operations process deviations
- Collaborate with clinical trial teams to identify operational issues and opportunities for improvement
- Manage clinical CAPAs and conduct root cause investigations related to clinical deviations
- Reviews essential documents for adherence to GCPs
Requirements:
- Minimum of bachelor's degree in a scientific or related discipline
- At least 3-5 years of eTMF experience, including experience in study start-up, study maintenance, and quality reviews
- 6+ years' experience in pharma with relevant experience in clinical trials related roles
- Experience performing quality assurance and/or quality management activities
- Experience with GCP vendor and site audits required
- Prior experience with BIMO inspections is strongly preferred
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