Global Clinical Operations Leader – Clinical Trial Manager
Location
North Carolina
Posted
5 days ago
Salary
0
Seniority
Senior
Job Description
Global Clinical Operations Leader – Clinical Trial Manager
Parexel
• Lead global clinical operations strategy and execution for assigned clinical trials. • Drive study startup including site selection, monitoring strategy, and operational planning. • Coordinate cross functional teams across geographies ensuring alignment on timelines quality and deliverables. • Monitor study progress including recruitment retention data quality and timelines and take corrective action when needed. • Identify risks early and implement mitigation and contingency plans. • Provide leadership direction and performance feedback to project team members. • Function as primary point of contact for sponsors on clinical operations topics. • Ensure compliance with ICH GCP regulatory requirements and internal processes. • Oversee maintenance and quality of study documentation and central files. • Support audits inspections and study closeout activities including database lock and archiving. • Provide strategic oversight of the integrated data delivery (IDD) framework and champion a proactive data-quality culture
Job Requirements
- Degree in life sciences, nursing, or equivalent clinical research experience
- Minimum of 5 years of experience leading clinical operations within a CRO environment
- Proven experience in roles such as Clinical Trial Manager, Clinical Project Manager or Clinical Operations Leader
- Experience leading complex global or multi-region studies
- Strong knowledge of ICH GCP regulatory requirements and clinical trial processes
- Experience coordinating cross functional teams and managing study timelines budgets and quality
- Proficiency with clinical systems and standard tools such as CTMS, EDC, and eTMF
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
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