Senior Clinical Project Manager
Our client, a Cork based CRO, are currently recruiting for a Senior Clinical Project Manager to join their team on a permanent basis. As Senior Clinical Project Manager you will manage a team of Project Managers to deliver high quality trials on time, within scope and budget.
As Senior Clinical Project Manager you will plan, coordinate and complete specialised clinical research projects and drive project management excellence initiatives. As Senior Clinical Project Manager you will work closely with Project Managers, the Operations Manager, Principal Investigators, the Clinical Trial Team and assigned third parties to ensure successful and timely completion of each research project as assigned.


Responsibilities:

• 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 trial 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 such as Investigators Brochures, briefing books, safety updates and review of clinical trial applications
• Collecting, processing and shipping/storage of protocol-required samples
• Liaise with Scientific Officer to organise statistical development plan
• Carry out projects with a view to establishing a library of general SOPs required for clinical research

• Bachelor’s degree, preferably in a scientific or health related field
• At least 5 years of clinical trials experience or relevant experience preferred with a strong working knowledge of the clinical research process and applied knowledge of clinical project management methodology, processes and tools
• Proficiency in use of project management tools and systems
• Experience in dealing with external project Sponsors
• Previous people management or supervisory experience preferred
• Strong leadership, influencing and organisational skills
• Appreciation of / experience in a compliance-driven environment
• Effective communication, negotiation, and problem-solving skills