Clinical Project Manager
- Experience Level
Hobson Prior are currently working with a leading health care organisation who are looking for a Clinical Project Manager to join them on a contract basis. You will be responsible for organizing and managing all operational aspects of the clinical project from conception to submission of the Clinical Study Report. This role requires 4 days office presents in Belgium.
- Manage the study start-up phase (e.g. protocol development, feasibility and site selection, IRB/EC/MOH approvals, and clinical supplies), the study conduct phase (e.g. enrolment and treatment (FPFV, LPLV, DBL)) and the study analysis phase (e.g. Clinical Study Report) of a clinical trial.
- Co-operate with all relevant groups to develop the clinical protocol and study timelines.
- Manage the start-up, ongoing activities, close-down and reporting of specific research projects.
- Work with Regulatory Affairs, Regional Medical Affairs as appropriate and vendors to establish appropriate study processes.
- Develop the investigation manual, informed consent, case report forms, and budgets related to each project.
- Ensure that clinical research monitors visit the research sites and that all reports, edits and issues arising therefore are correctly brought to a close.
- Accountable for ensuring that clinical research material is available, distributed, used and monitored correctly.
- Support selection of CROs, central labs and other vendors.
- Work with the data management staff in the development of CRF's and programs for the appropriate data management and analysis of the collected data.
- Support the writing of status reports and final reports of the data and in the closing down of clinical research sites.
- Authoring and review of standard operating procedures, standard forms and templates, and study-specific procedural documents.
- Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices.
- Strong oral and written communications skills and diplomacy
- Fluent spoken and written English.
- Master’s degree in science or Medical/Nursing field or equivalent.
- A minimum of 7 years’ experience in pharmaceutical, biotechnology or medical device company including CRO.
- Knowledge of GCP, ICH guidelines and regulatory requirements, including safety reporting for clinical trials.
- Experience with project management practices.
- Prior experience in leading a project team.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.