Description
Overview:Provides leadership to one or more teams and provides local strategic planning and organization to achieve successful study completion. The Sr. CSM maintains full ownership of the Affiliate portion of a study and ensures the effective and efficient delivery of country/region operational aspects in accordance with the study development plan and ICH/GCP standards, company SOPs, local operating guidelines and local regulatory requirements. The CSM also ensures the development and maintenance of productive relationships with our customers.Roles:
- Builds effective, high performing teams through influence, integration, motivation and optimization of team performance. Embeds the Roche values into the team(s) culture and promotes the team spirit
- Establishes Study Timelines, Budget, Resource, Risk and Quality Plans
- Oversees project, protocol and site feasibility and determines site selection and patient allocation (total and annualized) within the Affiliate and the HQ study
- Develops and manages Affiliate budget/financial plan, and forecasts using appropriate tools, ensures the team has the appropriate resources to effectively deliver high quality studies on time and within budget
- Makes an active contribution to therapeutic area strategy teams (e.g. Oncology Franchise Network), ensuring knowledge shared locally and globally
Requirements:
- University degree or equivalent in a medical/science-related
- 5 years proven experience in Clinical Research/Development or related industry
- Proven clinical development experience on the operational aspects of conducting clinical studies including vendor/CRO management, leading/working as part of a development team, implementing clinical development plans and coordinating study level activities to deliver data for filing or publication purposes including interaction with local Business Units
- Experience in project management including implementation of risk management plans and management of complex study budgets and resourcing plans
- Strong computer skills - experience using various computer applications including spreadsheets, email, word-processing software
- International travel required
To find out more about Real please visit www.realstaffing.com