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Job type: Permanent

Discipline: Program Manager / Director

Location: United States

Senior Director - Permanent - Cambridge, MA

��Ƶ 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

��Ƶ is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

��Ƶ Staffing is an equal opportunity employer.