
Clinical Compliance Specialist
2 weeks ago
Job Title: Clinical Compliance Specialist
Experience: 5 plus years of professional experience in a Quality department with expertise in Clinical Research.
Location: Various locations available.
Type: Full-time position in a dynamic organization.
Experience Level: Senior role for an experienced professional.
Department: Clinical Research Department
Purpose of this Role:
This senior level role will oversee end-to-end clinical trial activities from a quality perspective, ensuring compliance with regulations and guidelines. The successful candidate will have experience in managing quality compliance activities, establishing procedures, and training teams to ensure protection of human subjects and data integrity.
Responsibilities include developing and implementing risk-based approaches to quality compliance, identifying SOP training requirements, preparing and reviewing SOPs, conducting quality reviews of clinical trial activities, and maintaining oversight of team members' job-specific training.
Requirements & Qualifications:
- 5+ years' experience in a CRO/Pharma/Biotech organization with expertise in Quality activities in Clinical Research department.
- Strong analytical and problem-solving skills, with attention to detail and ability to spot inconsistencies.
- Proven track record of success in handling audits and inspections, with thorough knowledge of regulatory requirements and GCP guidelines.
- Excellent communication and conflict management skills, with the ability to work effectively in a matrix business environment.
Benefits:
Opportunity to work in a dynamic and fast-paced organization with a talented team.
Chance to develop and implement innovative solutions to quality compliance challenges.
Professional growth and development opportunities in a senior role.
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