A key client of ours is expanding their clinical operations team to help them prepare for global clinical studies to support those suffering from haematological and rare diseases. They are looking for a passionate, dedicated and motivated Lead CRA to help them manage and deliver this. This position involves the management of clinical trial sites and oversees clinical monitoring activities, as well as leading CRA teams. The company currently has over 10 interventional clinical studies ongoing, and supplies their products to numerous countries. If you want to be part of an enthusiastic and focused team that are devoted to delivering this product, then read on and apply!
You will be responsible for:
- Overseeing and managing clinical site monitoring activities
- Participate in the planning and execution of clinical studies
- Reviewing and managing teams
- Ensuring compliance with plans (clinical monitoring)
- Supporting the project manager with site data, recruitment strategy, data trends, etc.
- Proactively identifying risky issues and providing actionable plans for mitigation
- Attending meetings as required: study-related, company, external, departmental meetings, etc.
- Reviewing trip reports from CRO monitors
- Performing ongoing reconciliation of the Trial Master File (TMF) with content from site files
You will have:
- Bachelor's degree in the life sciences
- Strong background and knowledge of clinical research process
- Ability to handle multiple responsibilities and prioritise effectively
- Ability to work closely with monitors and CRAs and be supportive
- Knowledge of current regulations
- Experience as a lead CRA
- Experience on the sponsor-side
- German-language skills
Benefits:
- Being part of a dedicated, enthusiastic team committed to bettering the lives of patients
- Free fruit and breakfast
- Bonus package and other benefits
