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Project Planning Expert

2 months ago

Horley, Surrey, United Kingdom Novo Nordisk AS Full time

About the Role

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 at Novo Nordisk A/S. 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.

Main 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.

About You

We are looking for a passionate and proactive solution-orientated professional able to lead projects to implement change, coordinate activities, coach and develop others and to effectively communicate between all stakeholders.

Qualifications

  • 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.