What are the responsibilities and job description for the Clinical Regulatory Manager position at Talent Catalyst?
Job Summary
We are seeking an experienced Clinical Regulatory Manager to oversee and ensure the accuracy, compliance, and quality of work performed by Clinical Data Entry Specialists. The ideal candidate will bring a strong background in clinical research, regulatory compliance, and data management, coupled with a keen eye for detail and a commitment to maintaining high standards.
- Review and Audit Work: Conduct regular audits of data entered by Clinical Data Entry Specialists to ensure accuracy, consistency, and compliance with clinical research protocols and regulatory requirements.
- Ensure Regulatory Compliance: Monitor data abstraction and entry processes to ensure compliance with FDA, IRB, HIPAA, and other applicable regulations.
- Provide Feedback and Training: Offer constructive feedback to data entry specialists and provide ongoing training to improve accuracy and adherence to standards.
- Develop and Refine Processes: Collaborate with team members to enhance data entry workflows, develop best practices, and implement quality assurance protocols.
- Act as a Liaison: Serve as the primary point of contact for regulatory inquiries related to data management, both internally and externally.
- Report Findings: Prepare and deliver detailed reports on audit findings, compliance issues, and team performance to management and stakeholders.
- Stay Current on Regulations: Maintain up-to-date knowledge of clinical research regulations and data management standards, ensuring team practices align with industry requirements.
- Education: Bachelor’s degree in Life Sciences, Public Health, Clinical Research, or a related field. Advanced degree preferred.
Experience:
- Minimum 5 years of experience in clinical research, regulatory compliance, or data management.
- Previous experience managing or overseeing data entry teams is highly desirable.
Certifications:
- Regulatory Affairs Certification (RAC), Certified Clinical Research Professional (CCRP), or equivalent preferred.
Skills:
- Strong knowledge of FDA, IRB, and HIPAA regulations.
- Proficiency in data management systems (e.g., EDC systems, REDCap, Medidata).
- Excellent analytical, organizational, and communication skills.
- Ability to work collaboratively with cross-functional teams.
