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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Associate Clinical Project Manager


Reference:SCANGO-616117s Location: Dublin
Republic of Ireland
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Associate Clinical Project Manager
Our Dublin based client are currently recruiting for an Associate Clinical Project Manager to join their team on a permanent basis. As Associate Clinical Project Manager you will be responsible for maintaining knowledge and ensuring compliance with ICH-GCP, regulatory requirements, applicable guidelines, SOPs (Standard Operating Procedures), study protocols and project-specific procedures, lead and coordinate clinical trial activities for assigned studies in line with ICH-GCP and develop and maintain strong working relationships with external stakeholders/Sponsors.

Responsibilities

  • Manage and coordinate assigned studies, including review and assessment of study specific documents, development/review and assessment of country specific documents ensuring compliance with ICH-GCP, local regulatory and ethical requirements
  • Oversee/complete regulatory and ethic committee applications where required
  • Primary contact for Sponsor and collaborator groups for assigned studies and groups
  • Provide expertise and feedback to Sponsors and collaborator groups on the regulations and requirements within the assigned countries
  • Share knowledge of country and site-specific processes during the start-up of a trial and throughout to ensure compliance to the protocol can be maintained
  • Manage project-specific training and mentoring of junior staff members as assigned
  • Contribute to preparation for audits and inspections as required
  • Evaluate and document investigator, site and vendor selection as applicable
  • Overall responsibility for management of essential documents and Trial Master File where applicable
  • Responsible for the oversight of study initiations, monitoring and close-out as required for assigned studies
  • Pre-emptively identify potential issues and proactively manage resolutions and put in place, where possible, measures to minimize issues and risk for assigned studies
  • Ensure compliance with all trials you are responsible for
  • Input in SOP development and updates where appropriate
  • Organise, participate in and present at meetings and discussions with other teams and team members
  • Draft and finalise budgets, contracts, and roles and responsibilities prior to commencing study activities
  • Manage the study budget and associated financial activities for assigned studies where applicable
  • Update Head of Clinical Operations and Operations Lead where applicable for assigned studies on the status of all clinical trial activities
  • Prepare study reports and other scientific documents as required

Requirements
  • Science and/or medical or nursing background
  • Previous Medical or Clinical Research experience, oncology an advantage
  • Proven ability to deliver project goals and mentor junior level employee
  • In-depth knowledge of the Irish clinical trials environment
  • Excellent communication skills with the ability to represent the company at a national level