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Project Manager

  • Location: Van Nuys
  • £ Salary: £70000.00 - £90000.00 per annum per year
  • Job Type:Permanent

Posted 28 days ago

  • Sector: Careers at Hydrogen
  • Contact: Rebecca Keathley
  • Expiry Date: 10 June 2023
  • Job Ref: JN -052023-479063


  • Develop and execute clinical studies, which may include protocol development including risk rationales and study design, CRF development, investigational product supply management, budget/contract negotiation and regulatory document management.
  • Design, initiate, and coordinate in vitro diagnostic studies to collect data to support regulatory submissions and for use in future product development.
  • Take responsibility of ensuring the execution of clinical studies with the goal of adhering to target timelines, budget, and quality
  • Conduct and/or assist clinical teammates with on-site visits, including qualifications through close-outs; training clinical sites on implementation and conduct of study protocols.
  • Monitor conduct/compliance of clinical studies as related to GCP, SOPs, and regulatory requirements, utilizing knowledge of the diagnostic area sufficient to perform source data verification; occasional handling of biological samples may be required, based upon project need.
  • Assist clinical sites with IRB submission/documentation, as needed.
  • Proactively anticipate and identify issues; implement solutions, propose corrective actions in areas relevant to the role.
  • Evaluate and communicate the impact of risks, develop project quality and risk management plans for performance.
  • Manage staff and overcome challenges to ensure proper monitoring of studies and completion of project deliverables in accordance with project plan.
  • Manage cross-functional project team including protocol development team, regulatory team, physicians/investigators, study coordinators, study nurses, study recruiters, clinical research managers, and research associates.
  • Assist in identification, evaluation, and selection of investigative sites.
  • Communicate the status of the projects on a regular basis to the sponsors, principal investigator and stakeholder teams using graphic illustrations and concise report.
  • Ensure the scientific integrity of clinical studies and oversee clinical and research laboratory data QA/QC processes at the clinical trial sites.

Skills & Requirements

  • A minimum of 5 years of industry experience and a minimum of 2 years clinical study management.
  • Knowledge of accepted good clinical research practice (GCP) and procedures.
  • Experience with in vitro diagnostics and/or medical device industry.
  • Excellent organizational, time management, budget management, and problem-solving skills.
  • Hustle: Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
  • This is an onsite position.