What are the responsibilities and job description for the Senior Director, Clinical Compliance / Inspection Readiness position at Proclinical Staffing?
Senior Director - Permanent - Cambridge, MA
Proclinical is seeking a Sr. Dir. to join the Clinical Operations team with a focus on Clinical Compliance and Inspection Readiness.
Primary Responsibilities:
The successful candidate will be involved in leading compliance activities to ensure programs are always prepared for inspections.
Skills & Requirements:
- In-depth experience with CP, Regs., and quality systems.
- Bachelor's degree or equivalent in a relevant field.
- Experience in global clinical trials and operations.
- Proficiency in audit preparation, execution, and follow-up, including CAPA.
- Familiarity with computerized clinical trial records management technologies, particularly Veeva systems.
- Strong organizational, writing, and communication skills.
- Advanced knowledge of ICH/GCP guidelines and FDA regulations.
The Senior Director's responsibilities will be:
- Develop and deliver GCP and Inspection Readiness training for the Clinical organization.
- Implement processes and tools to maintain inspection readiness.
- Provide inspection readiness support and expertise to study teams, including risk mitigation.
- Prepare and execute plans for audits and regulatory inspections.
- Represent Clinical Compliance in audits and inspections, supervising preparation activities.
- Coordinate follow-up on audits, inspection responses, and corrective actions.
- Generate and communicate compliance and inspection readiness metrics.
- Drive continuous improvement in inspection readiness and conduct support.
- Develop controlled documents related to clinical study processes in compliance with global standards.
- Execute strategy for role-based curriculum and GCP training.
- Conduct compliance assessments and collaborate with Quality Assurance.
- Manage follow-up on audits and implementation of corrective actions.
- Provide training on Clinical Standard Operating Procedures to ensure regulatory compliance.
If you are having difficulty in applying or if you have any questions, please contact Nico Kohlwes at n.kohlwes@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
