Senior Clinical Project Manager - Cambridge

Responsibilities:

  • Collaborate with AD/D, Clinical Operations to ensure proper resourcing for assigned trials
  • Contribute to the Clinical Study Protocol and may participate in Protocol Concept Sheet
  • Develop outsourcing specifications for vendor requests for proposal and scope of work agreements
  • Participate in and guide study team in vendor selection
  • Lead the vendor(s) throughout the life of assigned clinical trial(s)
  • Select investigational sites with input from Clinical Development and vendors
  • Review, refine, and approve Clinical Operations Plans including study monitoring and other plans
  • Oversee investigative sites' adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with investigators, study site personnel and Clinical Research Organization Team members including Clinical Research Associates
  • Lead ongoing review of data to ensure quality and consistency
  • Plan and conduct investigator meetings and can support advisory board planning and conduct ad boards
  • Develop and lead study budget and possibly program budgets
  • Oversee site agreement/budget negotiation process
  • Develop and run study timelines (including recruitment) and potentially program timelines

 

Requirements:

Life Science Degree (ideally MSc)

  • Experience in clinical operations including project coordination, site management and monitoring or equivalent including project management experience or equivalent.
  • Deep understanding of country level regulations, ICH and GCP guidelines
  • Competence in cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs
  • Demonstrated ability to lead a cross-functional team in a matrix environment
  • Strong interpersonal and negotiation skills
  • Strong verbal and written communications and presentation skills
  • Proven problem solving and decision-making skills
  • Strong leadership, communication, management and organizational skills, conflict resolution, and team building skills
  • Ability and willingness to travel 25% of the time (internationally and domestically)

 

This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be.

 

To make an application please feel free to apply via this website, I am also available on LinkedIn to message regarding the role and will accept all invitations that refer to this advert - look for Dominic Mitchell at RBW Consulting.

 

Please note that owing to the high volume of applications we receive for our roles, if you have not received a response within 48 working hours, do please consider your application unsuccessful.

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