Associate Director/Director
Clinical Compliance
Confirmed live in the last 24 hours
Locations
Dorchester, Boston, MA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
PowerPoint/Keynote/Slides
Communications
Quality Assurance (QA)
Requirements
- 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)
Responsibilities
- 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
- Additional duties and responsibilities as required