Clinical Compliance Manager
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Role Overview
We are a healthcare and life-sciences-focused organization committed to maintaining the highest standards of clinical quality, patient safety, regulatory compliance, data integrity, and ethical clinical research.
Key Skills for This Role
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About Us
We are a healthcare and life-sciences-focused organization committed to maintaining the highest standards of clinical quality, patient safety, regulatory compliance, data integrity, and ethical clinical research.
The Role
We are seeking an experienced Clinical Compliance Manager to lead clinical compliance programs, GCP oversight, audit readiness, quality management, regulatory requirements, inspection preparedness, clinical documentation, and risk-based compliance activities across clinical research programs.
Key Responsibilities
- Develop and implement clinical compliance strategies, policies, procedures, standards, and governance frameworks aligned with applicable regulations and organizational objectives
- Establish risk-based clinical compliance programs covering clinical trials, research activities, investigators, sites, vendors, and clinical documentation
- Ensure clinical activities are conducted in accordance with applicable laws, regulations, Good Clinical Practice (GCP), ethical principles, approved protocols, and internal procedures
- Monitor developments in applicable clinical research regulations, regulatory guidance, ethical standards, and industry expectations
- Conduct clinical compliance assessments, quality reviews, audits, and risk-based monitoring activities
- Evaluate clinical trial processes, systems, documentation, and controls to identify potential compliance gaps
- Develop and maintain clinical compliance risk assessments and risk registers
- Identify critical and major compliance risks and develop appropriate mitigation strategies
- Coordinate internal audits, vendor audits, investigator-site audits, quality assessments, and other compliance reviews
- Support regulatory authority inspections and ensure clinical teams and documentation are prepared for inspection
- Develop inspection-readiness programs, mock inspections, readiness assessments, and remediation plans
- Manage audit findings, inspection observations, deviations, CAPAs, preventive actions, and compliance commitments through to closure
Candidate Profile
- The successful candidate should have strong experience in clinical compliance, clinical quality assurance, clinical operations, regulatory affairs, GCP, or a related life-sciences discipline.
What You'll Bring
- Proven experience in clinical compliance, clinical quality, clinical operations, GCP, or a related role
- Strong knowledge of ICH-GCP principles and applicable clinical research regulations
- Experience developing and implementing clinical quality and compliance programs
- Experience conducting or managing clinical audits and compliance assessments
- Strong understanding of regulatory inspection processes and inspection readiness
- Experience managing CAPAs, deviations, audit findings, and compliance remediation
- Strong knowledge of clinical trial documentation and TMF requirements
- Experience assessing investigator sites, CROs, vendors, and clinical partners
- Understanding of clinical data integrity and computerized-system compliance
- Strong knowledge of informed consent, protocol compliance, safety reporting, and investigator responsibilities
- Excellent analytical, documentation, communication, and stakeholder-management skills
- Strong risk-assessment and root-cause-analysis capabilities
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