The Project Manager will have a leading role in planning, coordinating and completing specialised clinical research projects; key responsibilities at each phase are outlined below.
They will need excellent communication, presentation skills and the ability to organise both themselves and others. They 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.
Key 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.
Phase 1: Trial inception
· 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.
Phase 2: Trial logistics
· 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.
Phase 3: Trial Close-out
· 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.
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