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Freelance Clinical Project Manager

1 month ago

London, Greater London, United Kingdom RBW Consulting Full time

RBW Consulting are genuinely thrilled to be partnered with one of the most exciting companies in the In-Vitro & Companion Diagnostics space in their search for Freelance Clinical Project Managers to work remotely in the UK.

You will be an integral member and Clinical lead to the project team in the development and delivery of our partners delegation of Authority to client companies, ensuring that client objectives are met and always exceeded. This will require the utilisation of a platinum standard approach to clinical research project management, internal and external stakeholder satisfaction as well as an innate work ethic that is aligned with the company's core values.

Key Responsibilities

  • Study design, strategy, planning (timeline, resources and budget management).
  • Coordinating clinical operational activities with internal stakeholders and clients, including pharma and central testing laboratories conducting the studies.
  • Development and /or review of associated documentation including such documents as CPSP, CSP, investigator brochure, informed consent for devices, risk-based monitoring plan and reports, in compliance with relevant regulations, guidelines and SOPs.
  • Client management, issue resolution, troubleshooting and ongoing coordination between all relevant groups to maintain compliance to protocol, patient safety and robust data collection and provision of regular updates to project progression.
  • Set up, manage and track studies, supporting study completion within agreed timelines and budget. Identify, enlist suitable study sites, and coordinate site management activities, with site audit, Site Qualification Visit, and study set up across USA, EU and Asia/Pac regions.
  • Understanding and application of relevant regulatory requirements and ethical approvals for conducting studies (e.g. IVDR requirements for EU, FDA requirements for USA, GCP, ISO20915).
  • Managing the study close out activities including, essential documentation filing and completion between study testing site(s) and sponsor TMF, ethical and regulatory bodies notification of study close, study close out report.
  • Generation of clinical study reports and related documentation to submit to regulatory authorities, ethical review boards and local agencies such as national competent authority.

Required experience

  • Degree in Life Sciences, Molecular Biology, or similar. PhD or equivalent experience highly desirable.
  • 3 years' clinical experience in IVD device's manufacturer; other devices or pharmaceutical experience in the capacity as device sponsor will be considered. Experience within oncology, IHC, NGS or molecular CDx would be desirable.
  • Working knowledge of regulatory requirements and industry practices e.g. IVDR, FDA, GCP, ISO14155, ISO20916, ISO13485, and QMS design control.
  • Experience of using TMF and/or eTMF and Smartsheet software.
  • Experience of authoring clinical study documents e.g. Clinical Strategy, Data management plan, CPSP, CSP, Investigator Brochure, Risk based monitoring plans, Informed Consent Documents etc.

Additional info

  • 1 FTE (0.8 FTE can also be considered)
  • 3 or 6 month contract (initially)
  • £75-90 p/h
  • ASAP start

Please apply here and Harry Henson will be in touch to discuss your application further