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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Senior Clinical Trial Project Manager


Reference:SCA012155 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Advisor

Senior Clinical Trial Project Manager
Our Dublin based client are currently recruiting for a Senior Clinical Trial Project Manager to join their team on a permanent basis. As Senior Clinical Trial Project Manager, you will be responsible for the planning, development and management of Clinical Operations activities.

Responsibilities

  • Oversee clinical project and site management activities including trial timelines, budgets, resources and vendors
  • Leads the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies
  • Participates in the identification of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites
  • Assists in the identification of contract research organizations and centralized services such as clinical laboratories; assesses qualifications and experience in relation to proposed research activities, and participates in final selection and contract negotiation
  • Oversees research technical and/or trial administrative staff, to include hiring, training, goal-setting, and distribution of workload
  • Develop clearly defined strategies and lead or contribute to assigned global, cross-functional interdisciplinary, high priority initiatives and process improvements
Requirements
  • Bachelor’s required, Master’s preferred
  • A minimum of 5 years of clinical operations experience, with increasing levels of responsibility, in the Pharmaceutical or Biotechnology industry
  • Three or more years of clinical program management experience at a trial sponsor, either in a large pharmaceutical company or in a biotech start-up environment is a plus
  • Therapeutic experience in infectious diseases, diabetes or oncology
  • Must have a thorough knowledge of clinical research concepts, practices, and EMA/FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods
  • Must be open to national and international travel as and when the job requires
  • Experience managing a clinical trial portfolio be able to demonstrate a proven track record of successfully leading cross-functional projects
  • Expert knowledge in coordinating key stakeholders required for completion of clinical trials including regulatory, operational, clinical, scientific, pharmacovigilance, monitoring, bioanalytics, manufacturing, laboratory, Qualified Persons and others
For more information please contact Sinéad Cullen on +353879500821 or [email protected]