Description
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. Provides study specific direction to study 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. Establishes study milestones and ensures accurate tracking and reporting of study metrics.Skills / Experience: Proven clinical development experience in 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. 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.
Education: Life sciences degree or nursing equivalent or substantial experience in a clinical research/a healthcare environment
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