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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Project Manager


Reference:SCACSL-257572 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Project Manager
Our client a clinical stage biopharmaceutical organisation, are currently recruiting for a Clinical Project Manager to join their experienced team. As Clinical Project Manager you will coordinate the day-to-day management of the clinical operations activities of the organisation. This is a super opportunity to join an excellent organisation at a very exciting stage. This role also offers hybrid working.

Responsibilities

  • Accountable for meeting or exceeding goals for clinical trial operations for development projects
  • Develop and maintain effective working relationships with all team members
  • Ensures the maintenance, tracking, and accuracy of operational data and milestones and facilitates the reporting of these to the Senior Management team
  • Contribute to the development of the study timelines, resources, budget, risk, and quality plans
  • Provide input into, and implementation of, the study level audit plan, quality, risk management and contingency plans. Ensure the completion of any corrective action plans resulting from site audits
  • Deliver the operational elements of the study and is the primary day-to-day contact for operational-related activities where appropriate
  • Provide the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
  • Regularly communicate the study status and timelines and escalates unresolved issues appropriately to the Senior Management team
  • Provide operational input into the selection of CRO/CRO partners and contract negotiation under the direction of the Senior Management team
  • Accountable for identification and selection of investigational sites, ensuring site initiation and maintenance activities with the focus on contracts and budgets that comply with local/regional requirements, data privacy requirements and quality standards in addition to routine site monitoring responsibilities
  • Participate in Clinical operational meetings, and contribute to the organisation of Investigator meetings, monitor workshops, site selection visits, CRO kick-off meetings and site initiation visits
  • Develop or provide operational input to the development of study documents, including study protocols, case report forms, patient information, informed consent forms and Investigator’s Brochure
  • Oversee the collation of feedback on study level documentation and ensure appropriate updates are made
  • Set-up and maintain archives for essential documents including Trial Master File, ensuring inspection-readiness
  • EC/IRB and Regulatory Authority clinical trial submissions (initial and amendments)
  • Coordinate responses to queries from Regulatory Authorities or EC/IRBs, including adaptation of procedures towards the new EU CT Directive, as implemented
  • Proactively manage actual recruitment versus planned patient recruitment status, communicates variance to, and implements contingencies in consultation with the Senior Management team
  • Maintain study drug requirements and oversee the global drug supplies level
  • Oversees the timely supply of all materials to sites and CRO/vendors
  • Oversees the reconciliation of invoices against scope of work and completed activities
Requirement
  • University Degree related to Life Sciences
  • Proven clinical operations experience in a pharmaceutical and/or biotech company with at least 5 years of project management experience in operational aspects of Phase I, II and/or III clinical studies
  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
  • Excellent written and verbal interpersonal communication, including an ability to effectively communicate on topics of a scientific nature, and influencing and customer care skills demonstrated by an ability to present clear instruction/direction to team members
  • Experience in psychiatry and/or neurology is a benefit
  • An entrepreneurial, business-oriented mindset
  • Good organization and tracking skills, as well as attention to detail
  • Mandatory fluent English (both oral and written) – other languages are an asset
For more information contact Sinéad Cullen on +353879500821 or [email protected]