Clinical Project Manager

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

• Degree in Life Science
• Prior experience working in Clinical Trials/Clinical Research
• Excellent communication skills
• Excellent organisational skills