Senior Global Study Lead - Late Phase
A fantastic opportunity has arisen for a Senior Clinical Study Lead in the UK. In this role you will be responsible for the global executions of large, complex clinical trials from study design through study close out.
- Providing operational input into protocol development
- Leading all aspects of and contributing to the development of study specific documentation e.g. case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
- Supervising set-up and maintenance of study systems such as Clinical Trial Management System (CTMS), Trial Master File (TMF) etc.
- Ensuring compliance with the clinical trial registry requirements
- Providing input into baseline budget and timeline development and managing the study against planned budget, timeline and results
- Leading risk assessment and identifies risk mitigation strategies at the study level
- Running feasibility assessment to select relevant regions and countries for the study
- Conducting site evaluation and selection
- Leading investigator meeting preparation and execution
- Monitoring progress for site activation and monitoring visits and acts on any deviations from plan
- Handling development and implementation of patient recruitment and patient retention strategies
- Monitoring data entry and query resolution and taking action on any divergence from agreed metrics
- Overseeing and providing input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation
- Ensuring data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations, and suspected serious non-compliance by sites
- Ensuring clinical project audit and inspection readiness through the study lifecycle and contributing to CAPAs as required
- Supervising study close-out activities and contributing to clinical study report writing and review
Skills and Requirements
- You have the capacity to understand and implement the strategic direction and guidance for respective clinical studies
- You can take a proactive and self-disciplined approach to managing projects with a developed ability to meet deadlines and prioritise
- You operate with a high degree of cross-functional agility using exceptional influencing and interpersonal skills
- Bachelors' degree with a minimum of 8 years of relevant industry experience.
- Direct experience managing global clinical trial operations is a must, including experience developing protocols and key study documents.
- You will also need technical proficiency trial management software and MS applications to be considered.
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