Description
Main Responsibilities- Provides direction and leadership to one or more clinical operations teams
- Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
- Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
- Oversees the development and maintenance of study specific manuals.
- Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
- Develops and manages clinical study budgets and contributes to staffing/resourcing plans; Communicates variances in the budget and action plan for resolution to senior management.
- Establishes study milestones and ensures accurate tracking and reporting of study metrics;Provides operational input into the development of protocol feasibility questionnaires.
- Proven clinical development experience of the operational aspects of all stages of clinical studies preferably working in a Global environment and/or including monitoring or leading affiliate teams, working with vendors and/or CROs, drug supply management and planning operational activities to achieve database lock.
- Experience of project managing aspects of a clinical study including development of timelines, budgets and resource plans.
- Strong knowledge of ICH /GCP and proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
- Well developed written and verbal communication skills demonstrated by an ability to present clear instruction/direction to teams at the same level in the organization and influence at higher levels in the organization.
- Bachelors Degree, Life Sciences preferred
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