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Trial Management Specialist
2 months ago
We are seeking a highly skilled and experienced Clinical Development Lead to join our UK Clinical Obesity and Liver team or Rare Disease and phase 1 team. As a key member of our team, you will be responsible for leading process oversight across all trials within a given therapy area to establish and embed trial management excellence.
Key Responsibilities- Lead trial management support for trials conducted in the UK in assigned programmes, including consistent and robust review of protocols and oversight of budgets.
- Ensure standardisation and consistency of trial management between all trials.
- Train, coach and develop UK CDC Trial Managers (CDC-TMs), in collaboration with Clinical Operations Excellence team.
- Drive clinical trial activities forward, achieving all project deliverables within agreed timelines and quality measures.
- Maintain current knowledge of therapeutic areas, SOP's, local and international regulations and ICH GCP guidelines.
- Identify and work with new initiatives from regulatory authorities, ethics/health research authorities and provide input to, and receive advice from NIHR, ABPI and other external bodies.
- Proactively review SOP updates to identify potential changes to UK trial management processes and highlight to/train where applicable.
- Minimum Bachelor's degree level in Life Sciences or equivalent.
- Proven track record of managing clinical trials including multi-centre studies.
- Experience in all phases of development and trial co-ordination on multiple studies.
- Robust project management experience and informal leadership.
- English fluency is required for this role.
You will be part of a highly motivated UK CDC team responsible for the planning, execution and completion of projects related to the development of new medicinal products. The UK CDC is a team of 90+ highly skilled and ambitious colleagues responsible for the planning and execution of clinical trial activities in accordance with the Product Development Plans of Novo Nordisk. We focus on continuous personal and professional development and exciting opportunities which arise within our international organization.
