Job Title: Associate Director/Director Clinical Compliance
Job Number: 32277
Location: Boston, MA
In this new role, the successful candidate will set the foundation of clinical program compliance and training. The candidate will work to support clinical teams across different stages of development in oncology. The successful candidate will be skilled at both understanding and applying global compliance regulations and processes to trials as they advance through clinical development. The position requires a collaborative partnership with cross functional team members both across the organization and with clinical sites. The candidate will work to ensure the needs of the teams are addressed with a collaborative outlook and be solution oriented to ensure standards, processes, and training are built with the needs of the business. The Associate Director/Director of Clinical Compliance will report to the Head of Development Operations.
- Collaborate with Clinical Development to ensure all trials are conducted in compliance with global regulations, ICH/GCP and applicable business processes and practices
- Review work and workflows of teams to ensure clinical compliance and provide guidance on training or improvement in processes
- Keep current with regulatory developments across industry as well as evolving compliance best practices
- Ensures an effective training program is maintained for all required compliance/regulatory training.
- Collaborate with client stakeholders to answer compliance questions or direct compliance issues to appropriate subject matter experts
- Ensure that compliance issues associated with clinical audits are properly evaluated and adequately addressed in collaboration with Clinical QA.
- Coordinate assessments of line functions to ensure adherence to stated policies/standards and lead associated work streams as needed
- Track and report on KRIs/KQIs for Clinical Development
- Bachelor’s degree in a life science or allied health field (e.g. nursing, medical or laboratory technology)
- At least 10 years of experience in clinical research with direct clinical compliance oversight
- Excellent written and oral communication skills
- Advanced working knowledge of GCP/ICH and other applicable regulations/guidelines
- Good organizational skills for the management of clinical development compliance and working in a fast-paced environment
- Proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and Egnyte)