Junior Clinical Project Manager

Highly Competitive
  1. Permanent
  2. Project/Study Manager (CSM/CPM)
  3. United Kingdom
Stevenage, England
Posting date: 21 Jan 2020

An established biotechnology company is advertising a vacancy for a Junior Clinical Project Manager position based in Stevenage. The company develops next-generation, patient-specific therapeutics that allow scientists to combat cancer without harming healthy tissues. This is an exciting opportunity to work with a dynamic and revolutionary organisation.

Job Responsibilities:

  • Create/review patient consent forms and provide relevant opinion.
  • Responsibility for delivery of components of clinical trials.
  • Manage and support start up activities for UK clinical trials sites including negotiation of contracts, site selection and review of essential regulatory documentation.
  • Manage timeline adherence, site budget adherence in conjunction with the sCPM and project quality deliverables.
  • Interact with and day to day management of vendors including supporting sCPM with vendor budget oversight.
  • Manage contract requirements.
  • Perform occasional interim monitoring visits, including site qualification, initiation and close-out, including the source data verification of CRFs and Data clarification forms as stipulated.
  • Co-ordinate the preparation and publication of data, reports and information, ensuring that these meet legislative, contractual and ethical requirements.
  • Maintain project documents in accordance with ICH-GCP and company SOPs and support the transition from paper to eTMF.
  • Develop and update with oversight of the sCPM study plans and documents, including the project plan, monitoring plan, and deviation plan.
  • Collaborate with site teams and CRAs to drive recruitment and high-quality data collection.
  • Prepares and support material preparation for external meetings, other study trainings and project meetings as required.
  • Prepared to travel nationally for the role.

Skills and Requirement:

  • Bachelor's degree (BSc, BA or RN equivalent) in biological or science-related field is essential.
    Skills/Specialist knowledge.
  • Strong clinical study experience in Oncology and or cell therapy.
  • Excellent collaboration and communication skills.
  • Knowledge of medical terminology and clinical patient management. ICH-GCP trained.
  • UK clinical trial experience in a senior or lead role.
  • Previous experience of site monitoring in early phase oncology studies ideally in melanoma or NSCLC.
  • Experience with ATIMPs an advantage.
  • Thorough knowledge of ICH-GCP guidelines and UK legislation.
  • Good interpersonal skills, including communication, collaboration, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, strategic thinking, manages complexity, punctuality, and collaboration in a team environment.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Jack O'Neill at 0203 846 0646 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.