Global Clinical Trial Lead – Senior Clinical Trial Manager
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Job Description
Global Clinical Trial Lead managing international clinical trial projects for Parexel. Ensuring compliance, stakeholder communication, and trial success across multiple locations.
Responsibilities:
- Provide leadership and direction to the trial team and be accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s.
- Responsible for steering and directing clinical trial activities, including patient and site engagement activities.
- Direct communication and interaction with multiple internal and external stakeholders, and team members on a global, multi-country or regional basis.
- Accountable for the accurate planning and operational feasibility of trial timelines; oversee trial preparation to ensure trial team members are aligned and on track.
- Supports development of trial level documents owned by other functions.
- Verifies and provides input into the country allocation and oversees trial feasibility.
- Maintains oversight during clinical trial conduct including adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation.
- In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting.
- Prepare and implement amendments of core documents, including training material updates/retraining as needed.
- Responding for timely, complete and compliant archiving of all relevant global documents in the TMF, including all required documents from vendors.
Requirements:
- Bachelor’s degree and minimum 6 years of relevant global trial management experience.
- Experience in early phase Oncology or Immunology is essential.
- Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
- Knowledge of ICH GCP and relevant regulatory guidelines/directives.
- Demonstrated interpersonal & leadership skills.
- Ability to understand and implement the strategic direction and guidance for respective clinical studies.
- Effective communication skills via verbal, written and presentation abilities.
Benefits:
- Health insurance
- Professional development opportunities
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