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Details

Clinical Project Manager


Reference:SCACSL-257572 Location: Republic of Ireland
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager

Clinical Project Manager
Our client biopharmaceutical organisation is recruiting for a Clinical Project Manager to join their team. As Clinical Project Manager you will coordinate the day-to-day management of the clinical operations activities of the organisation. Remote working with the ability to be in the Dublin office bi monthy is an option for this role.

Responsibilities

  • Provides direction to the Clinical Development Team (CDT)
  • Develop and maintain effective working relationships with other CDT members
  • Ensures that each CDT member is aware of his/her specific area of responsibility, contribution to, and participation in the CDT
  • Contribute to the development of the study timelines, resources, budget, risk, and quality plans
  • Accountable for meeting or exceeding goals for clinical trial operations for development projects
  • Ensure all operational tracking needs are identified to meet the needs of the team and facilitate reporting to the Managing Director or authorized representative of the Managing Director
  • Ensures the maintenance, tracking, and accuracy of operational data and milestones
  • Set up and maintain archives for essential documents including Trial Master File, ensuring inspection-readiness
  • Develop or provide operational input to the development of study documents, including study protocols and Investigator’s Brochure
  • Oversee the collation of feedback on study level documentation from the CDT and ensures appropriate updates are made
  • Provide input into, and implementation of, the study level audit plan, quality, risk management and contingency plans
  • Maintain study drug requirements and oversees the global drug supplies level
  • Keeps up to date with country/regional regulatory requirements
  • Deliver the operational elements of the study plan
  • Accountable for 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
  • Regularly communicate the study status and timelines and escalates unresolved issues appropriately to the Managing Director or authorized representative of the Managing Director
  • Chair CDT meetings, and contribute to the organization of Investigator meetings, monitor workshops, CRO kick-off meetings
  • Proactively manages actual recruitment versus planned patient recruitment status, communicates variance to, and implements contingencies in consultation with the Managing Director or authorized representative of the Managing Director.
  • Ensures the completion of any corrective action plans resulting from site audits
  • Coordinates responses to study questions or issues from Health Authorities or EC/IRBs, including adaptation of procedures towards the new EU CT Directive, as implemented
  • Oversees the timely supply of all materials (from internal and external parties) to sites and CRO/vendors
  • Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
  • Provides operational input into the selection of CRO/CRO partners and contract negotiation under the direction of the Managing Director or authorized representative of the Managing Director
  • Primary day-to-day contact for operational-related activities where appropriate
  • Oversees the reconciliation of invoices against scope of work and completed activities
Requirements
  • University Degree related to Life Sciences (e.g., human biology, biochemistry, biology, pharmaceutical science, medical doctor, veterinary medicine, chemistry, engineer).
  • Proven clinical operations experience in a pharmaceutical and/or biotech company of at least 4 years in project management of operational aspects of clinical studies, including development of timelines, budgets and resource plans in complete and/or partially outsourced settings
  • Experience across a range of therapeutic areas, experience in psychiatry and/or neurology is a benefit
  • Experience of leading clinical trial teams, working with vendors (CROs, IVRS, central laboratories)
  • Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines
  • Updated knowledge of ICH GCP requirements
  • Self-driven and motivated team player
  • Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
  • Excellent written and verbal interpersonal communication, influencing and customer care skills demonstrated by an ability to present clear instruction/direction to team members
  • Good organization and tracking skills, as well as attention to detail
  • Mandatory fluent English (both oral and written) – other languages are an asset