Description
Main Responsibilities and Accountabilities: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. Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO 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. 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 the GSL. Establishes study milestones and ensures accurate tracking and reporting of study metrics. Provides operational input into the development of protocol feasibility questionnaires.
Skills & Knowledge:
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. Experience of working as part of a large team and leading small study or functional teams, with a proven ability to be an active member of the team and motivate and lead a small team to deliver against commitments. Well developed written and verbal communication skills.
Education:
Life sciences degree or nursing equivalent or substantial experience in a clinical research environment.
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