Clinical Research Project Lead
hace 6 días
We are seeking an experienced and skilled Global Study Manager to join our clinical trials team. In this role, you will be responsible for managing the planning, execution, and oversight of clinical studies in accordance with global program strategies.
Key Responsibilities:
- Lead cross-functional Local Study Teams (LSTs) to ensure successful study execution
- Develop and contribute to program/study-specific materials, such as monitoring plans and training documents
- Accountable for site-level goal setting and study-specific deliverables at local sites
- Contribute to CRA, Investigator, and Study Coordinator training
- Oversight and monitoring of vendor activities, including laboratories and equipment provisioning
- Country-level input into the Country Operational Plan (COP) and partnership with DFM teams
- Responsible for approval of Baseline and Revised Enrolment Plans (Country Level)
- Monitoring study execution against timelines, deliverables, and budget at country level
- Translating global start-up requirements into local country targets
- Monitoring data flow metrics and acting upon trends and analysis
- Facilitating resolution of cross-functional study-specific issues
- Escalating issues related to delivery, timelines, or budget to GCMs or TMT leads
- Executing regulatory agency inspection readiness activities
- Collaborating with local teams to ensure country-level study delivery aligns with global expectations
- Identifying risks, implementing mitigation strategies, and resolving issues at country/site level
Requirements:
- Bachelor's degree in a health, life sciences, or relevant field of study
- Minimum 5-6 years' experience in clinical research or project management and site management
- CRA experience preferred
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