Clinical Trial Manager
Company: Affinity Home Health Care Inc
- Location: Bridgeport, United States
- Employment type: Full-time
- Posted: Today
- Offer language: English
Job description
Senior Clinical Trial Case Manager to lead end-to-end case management for global biotechnology and pharmaceutical studies. Own case processing, review safety data, and ensure accurate safety documentation while prioritizing patient safety and adherence to ICH-GCP and applicable global regulatory standards.
Key Duties
- Manage clinical trial case processing and safety documentation end-to-end
- Conduct quality-focused review of case data for accuracy and completeness
- Ensure compliance with ICH-GCP and global regulatory requirements
- Partner with investigators, CROs, and internal stakeholders to support safe study conduct
- Drive readiness for inspections and support quality/audit activities
- Mentor and support junior case management staff
Qualifications & Skills
- Strong understanding of clinical safety case management and regulatory expectations
- Proven attention to detail and commitment to data integrity
- Excellent cross-functional communication and collaboration skills
- Ability to lead, mentor, and influence quality across the safety process
