Sr. Assessment Manager/Principal Assessment Manager
This position is responsible for supporting the assigned clinical program(s) as the GCP Compliance lead and key point of contact. It requires building and maintaining strong relationships with multiple internal and external team members and cross functional groups.
Strong knowledge of global GCP regulations, and excellent communication and organizational skills are required. In order to be successful in this position, the candidate must possess dynamic interpersonal and teamwork skills.
- Serve as a subject matter expert by providing GCP Compliance advice to the assigned clinical program(s), including updates for applicable regulations.
- Risk-based GCP audit and oversight strategy for assigned programs
- Provide assistance or guidance to the responsible parties in developing and completing Risk corrective and preventive action plans.
- Provide reviews of protocols, amendments, and other study specific documents as requested for compliance with internal standards, international regulations and ICH GCP guidelines.
- Assist with tracking GCP Compliance audit trends and group metrics.
- Report significant and/or serious ongoing quality deficiencies to GCP Compliance Management.
- Assure the integrity and quality of clinical data by independently managing internal and external; domestic and international GCP audits for the assigned program(s). Audits include, but are not limited to: investigator study sites, vendors, study reports, and internal systems.
- Participate as a member of the inspection preparation and execution team for clinical inspections from global health authorities.
- Escalate significant compliance risks to senior management, and ensure appropriate corrective actions
- This position will require domestic and international travel < 25% of the time.
Minimum 12 to 15 years experience in the Pharmaceutical, Biotechnology or Medical Device industry; in Clinical Quality Assurance/Regulatory Compliance or equivalent.
- Current knowledge of US Code of Federal Regulations and ICH Guidelines governing clinical trials and recent initiatives.
- Must be detail oriented, with excellent oral and written communication skills. Also, must be able to partner with a diverse group of staff/international consultants with different strengths and skills and have the ability to prioritize work, manage multiple projects, while maintaining quality.
- Ability to work independently and as part of a team in a very busy work environment.
- Experience in international compliance and auditing.
- Experience with Regulatory Authority Inspections, including sponsor and clinical site preparation and support, is preferred
- Auditor certification is a plus.
- Minimum 12 to 15 years’ experience in the Pharmaceutical, Biotechnology or Medical Device industry; in Clinical Quality Assurance/Regulatory Compliance or equivalent.
- GxP Compliance
- Clinical Operations
- Clinical Science
- Development Science Quality
- Clinical Data Management
- Medical Writing
- Regulatory Affairs
- Pharmacologic Sciences
- Medical Affairs
- Clinical Investigators
- Study Site Personnel
- Clinical Service Providers
Minimum of a bachelor's degree in science field required.
No Supervisor Responsibility