Global Studies Manager
Reference Number: 895106-W
Type of placement: Contract, 12 months, with an option to be extended
Location: Switzerland, North West
Provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more Oncology studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.Main Responsibilities:
Qualifications and Experience:
- Develop operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management
- Build effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables
- Develop and maintain effective working relationships with study management team members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams
- In collaboration with functional management, coach, mentor, support, and provide study specific direction to Study Management team members
- Contribute to the development and management of the study timelines, resources, budget, risk and quality plans
- Ensure operational tracking tools are identified, including systems to meet the needs of the operations team and ensure reporting to the Global Study Leader
- Develop and manage clinical study budgets (including HQ budget) and contribute to staffing/resourcing plans.
- Establish study milestones and ensures accurate tracking and reporting of study metrics
- Lead the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the Global Study Leader and Operations Program Leader.
- Oversee forecasting of clinical/non-clinical supplies
- Design drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and GSL
- Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.
- Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.
- Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
- Study manager with experience of managing trials globally, leading and coordinating the implementation activities in multiple countries
- 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
- Experience in Oncology and/or Haematology in an advantage
- Fluent in both written and spoken English
- Relevant working/residency permit or Swiss/EU-Citizenship required