Global Study Manager II
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Job Description
Global Study Manager providing leadership for clinical trials at Parexel. Ensuring successful delivery and engagement across multi-country trials.
Responsibilities:
- Provide leadership and direction to the trial team
- 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; and oversight of trial preparation to ensure trial team members are aligned and on track
- Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring)
- 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
- Supports budget oversight, including regular clinical quality monitoring, SMC/DMC management and safety reporting
- Prepare and implement amendments of core documents, including training material updates/retraining as needed.
- Support authority/ethics response to requests as applicable
- Ensures timely cleaning and delivery of clinical trial data
- Coordinates and supports trial medical writer in providing the CTR.
- Responsible for timely, complete and compliant archiving of all relevant global documents in the TMF
- Support results/documents disclosure of global registries.
Requirements:
- Bachelor’s degree and minimum 6 years of relevant global study management/leadership experience
- Experience with oversight of CROs and vendors
- Experience in managing per subject costs, vendor and ancillary and monitoring costs projections and spend
- Fluency in written and spoken English required
- Ability to work outside of core business hours, as required, to support global trials or initiatives
- Ability to travel, as required, including IMs, vendor kick off and re-set meetings, and client internal global or department level meetings
- 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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