Description
Primary responsibilities include:- Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
- Develops and maintains effective working relationships with study team members, with particular focus on affiliate teams, external CROs and co-development partner study teams
- 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
- Ensures operational tracking tools are identified, including systems to meet the needs of the operations team
- Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans
- Establishes study milestones and ensures accurate tracking and reporting of study metrics
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 CROs, drug supply management and planning operational activities to achieve database lock
- Good knowledge of ICH / GCP
- Experience working as part of a large team and leading small study or functional teams
- 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
To find out more about Real please visit www.realstaffing.com