Responsible for compliance oversight and control of regulated GCO activities focusing on program/trial level delivery.
Act as single point of contact for Clinical Trial Teams for GCP Compliance.
Provide management and day-to-day support for program/trial level quality issues, deviations and quality management.
Coordinate and support Clinical Trial Teams for audits and inspections.
Deliver the GCO self-assessment strategy related checks and controls.
Support cross-functions risk assessments and monitor relevant indicators/metrics/thresholds.

Advanced degree in science, engineering or relevant discipline.
8+ years industry experience in clinical operations and trial management.
Strong understanding of clinical research international standards and regulatory requirements from Health Authorities.
Audits and inspections experience highly desirable.
Organizational and analytical skills associated with an aptitude in quality management and continuous improvement.
Critical thinking ability and risk management and risk-based knowledge and mindset.
Strong skills to facilitate/optimize contribution of team members as individuals and members of a cohesive team.
Ability to work effectively in a matrix cross-functional environment.
Ability to make & communicate difficult decisions with strong written and verbal communication skills.
Self-awareness, willingness to further develop own strengths and explore opportunities for improvement.
Must be fluent in English.

GCP Compliance Manager – Program, Study

Key skills