This role is responsible for leading operational compliance activities within a defined region, ensuring clinical trial operations meet regulatory requirements and internal quality standards. The specialist conducts thorough compliance reviews of trial documentation, maintains independence from routine operations, and supports the organization’s commitment to quality and regulatory adherence.
Key Responsibilities
- Perform compliance evaluations of clinical trial documents at research sites to verify adherence to regulations and internal standards.
- Act as a dedicated compliance resource, distinct from operational quality control, to ensure objective oversight.
- Support regional teams in developing effective Corrective and Preventive Action (CAPA) plans, ensuring alignment with SOPs, regulations, and best practices.
- Maintain accurate records of regional CAPA owners and ensure timely resolution of findings through structured follow-up processes.
- Lead root cause analyses to inform CAPA development and process enhancements where necessary.
- Develop and manage standardized processes for operational compliance, including risk-based assessments, reporting mechanisms, and performance tracking.
- Monitor quality control activities, CAPA implementation, and process effectiveness across the region.
- Compile and report quality metrics and trend data to management, including RAG status reports, to support decision-making.
- Review audit findings, inspection outcomes, and noncompliance reports to safeguard participant safety, data integrity, and regulatory compliance.
- Collaborate with internal governance bodies to strengthen quality systems and operational processes.
- Assist in preparing for client audits and regulatory inspections, including documentation readiness and follow-up on findings.
- Deliver training on GCP, compliance principles, and quality topics to enhance team expertise.
- Uphold confidentiality in line with data protection and GCP requirements.
Qualifications
Candidates must have at least five years of experience in clinical research, including roles such as clinical auditor or monitor, with direct exposure to audits and regulatory inspections. A strong foundation in GCP and quality regulations is essential, along with proven ability to develop and revise SOPs. The ideal candidate is highly organized, detail-oriented, and capable of working independently while managing complex projects and stakeholder relationships. Experience in a matrix environment and willingness to travel regionally are required. Excellent communication and training skills, along with the ability to escalate issues appropriately, are critical to success in this role.
