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Global Study Manager II
Location
Spain
Posted
107 days ago
Salary
0
Seniority
Senior
Job Description
Global Study Manager II
Parexel
• 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.
Job 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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