Senior Project Manager - Early Phase
Job Description To assist in the conduct of Early Phase studies across all therapeutic areas in accordance with ICH Good Clinical Practice (GCP) and following local regulatory requirements and relevant Standard Operating Procedures (SOP’s). Liaison with PAREXEL staff such as the study coordinator, Principal Investigator, Pharmacist and recruitment personnel to ensure the smooth running of Early Phase studies. Attend client meetings to represent the department. Liaison with Sponsor personnel ensuring communication channels are open at all times and that the Sponsor is kept adequately appraised of study progress. Ensuring all study milestones are met. Management of project related meetings (both internal and with Sponsor personnel) and attendance at such meetings where appropriate. Liaison with Regulatory personnel regarding the timely progress of CTA applications to the MHRA. Liaison with and submission of documents to Ethics Committees. Development and review of study protocols. Review of study related documents (including Case Report Forms) and distribution to third parties where appropriate. Oversee the timelines for ClinBase set-up of studies. Management of monitoring visits, overseeing the resolution of data queries. Contact with sub-contracted parties where appropriate to ensure timely study conduct. Monitoring and managing the study budget. Participate in general departmental activities to assist in continuous improvement of the department. Skills Strong organisation and communication skills. IT literate. Client focused approach to work. Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Education Life Science degree and/or nursing background. Strong background in Project Management, preferably in Early Phase.