Title: Associate Director of Clinical Compliance
Summary: A global biotech leader is currently seeking a driven and motivated Associate Director of Clinical Compliance to lead their headquarters in Boston. As the Clinical Compliance representative, you will be responsible for supporting clinical trial teams across different stages of development and multiple therapeutic areas for inspection readiness.
The AD of Clinical Compliance will be responsible for…
- Cross-functionally collaborating with clinical trial teams to answer compliance questions or direct to appropriate SMEs
- Ensuring all trials conducted are in compliance with internal policies and procedures, GCP/ICH, and global regulations
- Identifying compliance and communication risks
- Evaluating and addressing compliance issues related to clinical audits or inspections with R&D Quality study teams
- Training and preparing trial teams
The AD of Clinical Compliance should have the following qualifications:
- Bachelor's degree
- Minimum 8 years of experience in clinical research
- 4+ years of direct responsibility in clinical compliance and inspection readiness
- Extensive knowledge of GCP/ICH regulations/guidelines
- Preferred: Advanced degree
If you're interested in this Associate Director of Clinical Compliance role, then please don't wait to apply!