Senior Clinical Project Manager

  • Salary: Competitive
  • REF Number: 00052736
  • Consultant: Jim Gleeson
  • Contact: 01438 842973
  • Date Published: 08.03.2022
  • Closed Date: 25.03.2022
  • Sector: Biotechnology
  • Location: London, London
  • Discipline: Clinical Operations

Jim Gleeson is recruiting for a Senior Clinical Project Manager to join an innovative biotechnology company with a large and diverse product pipeline. You will need to work from their central London offices on a hybrid basis.

Competitive salary and benefits package

RESPONSIBILITIES:

As Senior Clinical Project Manager you will play a lead role in planning, co-ordinating and the efficient execution of multi-centre phase I and II oncology clinical trials or programs, ensuring delivery of associated activities to time, cost and quality.

Key duties will include:

  • Working with internal and external teams and providers to ensure clinical trials and development plans are initiated, managed and delivered in line with company strategy- Writing study protocols and related study documents, from the initial scientific discussion
  • Contributing to regulatory filing packages including but not limited to briefing books, regulatory submissions and responses
  • Managing the selection process for vendors including CRO/lab/DM/PV
  • Taking on the role of Asset Lead, working with the cross functional team from across the company to manage and accelerate the development program
  • Working with the Head of CMC to ensure drug supply for clinical activities
  • Ensuring clinical trials/program meets all GCP/ICH Guidelines and are inspection ready, via oversight of TMF

QUALIFICATIONS:

As Senior Clinical Project Manager you will require:

  • An advanced degree in life sciences, PhDdesirable
  • Extensive experience of running multi-centre, international clinical trials in oncology or similar experience of working across various therapeutic areas
  • Extensive biotech experience
  • Phase I and II trial experience with ability towork-up assets in preparation for IND/CTA regulatory submission
  • Vendor selection and management experience
  • Excellent communication and presentation skills
  • Willing to travel internationally if required

Apply: Entitlement to work in the UK is essential. For more information please contact Jim Gleeson on 01438 842973 or email jgleeson@ckgroup.co.uk. Please quote reference 52736 in all correspondence.

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