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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Project Manager


Reference:SCAJUR-350562 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Assistant

Clinical Project Manager
Our client, a Cork based CRO, are currently recruiting for a Clinical Project Manager to join their team on a permanent basis. As Clinical Project Manager you will have a leading role in planning, coordinating and completing specialised clinical research projects. You will be responsible for the day-to-day management of clinical research studies and will work closely with the Operations Manager, Principal Investigators, Clinical trial team and assigned third-parties to ensure successful and timely completion of each research project as assigned.

Responsibilities

  • Lead the Clinical Trial Team and liaise with assigned third parties to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures.
  • Coordinate the clinical trial set-up and development process, adhering to the organisations SOPs and quality guidelines for the development of trial-related documents and processes
  • Recruit, train and delegate responsibilities to all members of the clinical trial team
  • Support/co-ordination of the writing of trial-specific documents (i.e. lab manuals, SOPs etc) in collaboration with the Operations Manager or Sponsor representative as appropriate
  • Liaise with Data and Quality Managers in the development of trial-specific tools (i.e. source documents, CRFs, eligibility checklists and logs)
  • Liaise with Recruitment Officer for the development of a recruitment plan
  • Ensure all trial procedures are developed according to the relevant Good Clinical Practice and Data Protection Guidelines
  • Employ standard project management techniques to ensure the trial is conducted according to outlined timeline – forecast potential challenges and prepare alternative methods to account for these, if required
  • Organise internal SIV and present trial initiation plan to all members involved in the trial setup and conduct
  • Appraise and supervise members of the clinical trial team and work with them to ensure successful completion of the project
  • Provide clear feedback to members of the clinical trial team about the trials timelines and performance
  • Implement problem-solving measures if the trial is underperforming in any aspect
  • Work with the Operations Manager, QA and Data Manager to identify potential quality issues and implement actions to resolve them. Ensure timely availability of reports / activities needed to track trial performance. Escalate issues endangering data quality to the next level if no solution can be achieved
  • Accountable for accuracy of trial information in all trial databases and tracking systems. Liaise with Data Manager to conduct Blinded Data Review at assigned timepoints
  • Monitor, in conjunction with the relevant PIs, adverse events and ensure appropriate action
  • Responsible for maintaining appropriate logs of investigational product, subject screenings, subject visits, etc
  • Communicate effectively with trial sponsors, clinical trials team, recruitment officer, QA, data manager, administrative staff and subjects on all trial related issues
  • Serve as a liaison between physicians, subjects, clinical trial team and sponsors
  • Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates and review of clinical trial applications (as needed).
  • Collecting, processing and shipping/storage of protocol-required samples
  • Liaise with Scientific Officer to organise statistical development plan
  • Perform other duties as assigned
  • Carry out projects with a view to establishing a library of general SOPs required for clinical research
  • Contribute to the management and effectiveness of the organisation as a member of its management team
Requirements
  • Degree in Life Science
  • Prior experience working in Clinical Trials/Clinical Research
  • Excellent communication skills
  • Excellent organisational skills
For more information contact Sinéad Cullen on +353879500821 or siné[email protected]