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Global Clinical Operations Leader – Clinical Trial Manager
ParexelGlobal Clinical Operations Leader leading clinical operations strategy for clinical trials at Parexel. Ensuring compliance and quality while managing global teams and stakeholders.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
clinical operationsstudy startupsite selectionmonitoring strategyoperational planningrisk managementdata qualityclinical trial processesproject managementdata delivery framework
Soft Skills
leadershipcommunicationcross functional coordinationperformance feedbackstrategic oversightproblem-solvingteam alignmenttimelines managementquality assurancestakeholder engagement
Tools & Technologies
CTMSEDCeTMFclinical systemsdatabase lockarchivingaudit supportinspection supportstudy documentationcentral files
Industry Keywords
ICH GCPCRO environmentclinical trialsglobal studiesmulti-region studiescompliancestudy closeoutdata-quality culturerisk mitigationcontingency plans
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities