Description
Responsibilities:- 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 (for outsourced teams) and co-development partner study teams
- Oversees the development and maintenance of study specific manuals created by the GSA
- Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL
- Develops and manages clinical study budgets and contributes to staffing/resourcing plans
- Provides operational input into the development of protocol feasibility questionnaires.
Requirements:
- Bachelor's Degree plus Clinical development experience of the operational aspects of all stages of clinical studies
- Experience of project managing operational aspects of a clinical study including development of timelines, budgets and resource plans
- Good knowledge of ICH GCP
- Experience of working as part of a large team and leading small study or functional teams
To find out more about Real please visit www.realstaffing.com