What are the responsibilities and job description for the Associate Director/Director, Clinical Operations Compliance position at Stratacuity: Proven Scientific Placement?
Associate Director/Director, Clinical Operations Compliance (Contract)
Our Cambridge based client is seeking a consultant to serve as the clinical operations compliance leader across a growing development portfolio. This individual will partner closely with Clinical Operations, Quality, Regulatory, Data Sciences, Pharmacovigilance, and Clinical Research teams to ensure inspection readiness, strengthen operational processes, and drive compliance excellence across clinical programs.
This is a highly visible leadership role responsible for establishing and maintaining Clinical Operations standards, overseeing SOP development and management, supporting vendor governance, and ensuring adherence to GCP, ICH, FDA, EMA, and other applicable regulatory requirements.
Key Responsibilities
- Lead Clinical Operations compliance initiatives, processes, and standards
- Drive SOP, work instruction, and TMF governance programs
- Ensure inspection readiness through oversight, training, and continuous improvement activities
- Partner cross-functionally to support quality and compliance objectives across clinical trials
- Provide compliance oversight for trial management, monitoring, vendor management, TMF, data operations, investigational product management, and study closeout activities
- Support issue escalation, CAPA development, and resolution management
- Contribute to global regulatory submissions and inspection preparation activities
- Serve as the internal subject matter expert for clinical compliance and regulatory requirements
Qualifications
- Bachelor's degree in a scientific discipline; advanced degree preferred
- 10 years of biotech, pharmaceutical, or CRO experience
- 8 years of clinical operations experience
- Leadership experience managing and mentoring teams
- Demonstrated success supporting complex clinical development programs and regulatory inspections
- Deep understanding of GCP, ICH, FDA, EMA, and clinical trial compliance requirements
- Strong experience with SOP development, TMF management, vendor oversight, and inspection readiness
- Exceptional relationship-building, communication, and problem-solving skills
This opportunity is ideal for a compliance-focused clinical operations leader who enjoys building scalable processes, driving organizational excellence, and partnering across functions to support the successful execution of clinical development programs.
Salary : $110 - $150