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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Trials Manager


Reference:SCAAPS-161268 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Clinical Trials Manager
Our client, a growing biotech organisation are currently recruiting for a Clinical Trials Manager to join their organisation on a permanent basis. As Clinical Trial Manager you will be responsible for coordinating & supporting clinical operations activities.

Responsibilities

  • Provide support to the Clinical Development Team (CDT)
  • Develop and maintain effective working relationships with other CDT members
  • Contribute to the development of study timelines, resources, budget, risk, and quality plans
  • Accountable for meeting or exceeding goals for clinical trial operations for development projects
  • Ensure that all operational tracking needs are identified to meet the needs of the team and facilitate reporting to the Senior Management team
  • Ensure 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 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 oversee the global drug supplies level
  • Keep up to date with country/regional regulatory requirements
  • Delivers the operational elements of the study plan
  • Accountable for ensuring site selection (feasibility studies), 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
  • Regularly communicate the study status and timelines and escalate unresolved issues appropriately to the Senior Management team
  • Participate in CDT meetings, and contribute to the organisation 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
  • Ensure 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
  • Provide 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 Senior Management team
  • Primary day-to-day contact for operational-related activities where appropriate
  • Oversee 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 operational aspects of Phase I, II and/or III clinical studies, including:
    • Identification and selection of investigational sites, interactions with Principal Investigators and KOLs
    • Site organization, monitoring and data cleaning
    • Ethics Committee and Competent Authority submissions
    • International experience in multi-centre, multinational studies
    • 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/overseeing external vendors (CROs, IWRS, central laboratories, data management, biometrics)
  • 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