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Details

Director of Clinical Operations


Reference:SCADAF-452348 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed

Director Clinical Operations
Our client, a biotech start-up are currently recruiting for a Director of Clinical Operations to join their growing team on a permanent basis.


Responsibilities

  • Provide direction to and line management of the Clinical Operations Team
  • Develop and maintain effective working relationships within and outside the Clinical Operations Team
  • Ensure each Clinical Operations team member is aware of their specific area of responsibility, contribution to, and participation in the overall clinical development plan of the organisation
  • Responsible for 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 the maintenance, tracking, and accuracy of operational data and milestones
  • With the Clinical Operations Team, 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 Clinical Development Team and ensure 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
  • Keep up to date with country/regional regulatory requirements
  • With the Clinical Operations Team, deliver the operational elements of the study plan
  • Ensure 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
  • Chair Clinical Operations team meetings, and contribute to the organization of Investigator meetings, monitor workshops, CRO kick-off meetings
  • Proactively manage actual recruitment versus planned patient recruitment status, communicates variance to, and implements contingencies in consultation with the Senior Management team
  • Ensures the completion of any corrective action plans resulting from site audits
  • Coordinate responses to study questions or issues from Health Authorities or EC/IRBs, including adaptation of procedures towards the new EU CT Directive, as implemented
  • Oversee the timely supply of all materials (from internal and external parties) to sites and CRO/vendors
  • With the Clinical Operations Team, provide day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
  • Provide operational input into the selection of CRO/CRO partners and contract negotiation
  • 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 line management experience of a clinical operations function of at least 2 years
  • Proven clinical operations experience in a pharmaceutical and/or biotech company of at least 8 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