Description
Duties:- 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.
- Creates team culture and promotes team spirit. Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
- In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.
- Oversees the development and maintenance of study specific manuals created by the GSA.
- Contributes to the development and management of the study timelines, resources, budget, risk and quality plans Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL.
Skills
- Experience 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 operational aspects of a clinical study including development of timelines, budgets and resource plans.
- Good knowledge of ICH GCP Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
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