Senior Clinical Study Manager
Hobson Prior are currently looking for a Senior Clinical Study Manager to join a brilliant biotech organisation on a permanent basis located in Boston. Our client is focused on both early and late phase programs.
Please note that to be considered for this role you must have the right to work in this location.
- For this role, you will be accountable for the selection and management of CROs and study-connected vendors, which involves outlining CRO or vendor accountabilities, deliberating the contract and change orders and forming a fair and precise budget.
- Contribute to the development of clinical study plans and timelines, with particular contributions into operational features of the study and recognition of cost drivers and prospects for effectiveness.
- Monitor the development/amendment of clinical study documents, which involves for example: study protocols, informed consent forms and the preparation of the regulatory files.
- Accountable for guiding and handling the operational implementation of one or various clinical studies in terms of cost, timelines and effectiveness while guaranteeing data quality and integrity.
- You will partake in the selection of investigational sites, prepare recruitment projections and selection of countries and sites in cooperation with study team and CRO.
- Supervise clinical trial site's adherence to relevant guidelines through evaluation of supervisory reports, CQA-GCP audit report, discussions with investigators, study site staff, CRAs and any other CRO/designee staff.
- The ideal candidate will contribute to study data evaluation and any other evaluation actions as allocated rendering to GCP.
- Any other assigned duties.
- Prior involvement in an international trial management role.
- Currently based in the Boston region or keen to relocate to the area.
- Familiarity working within a biotech environment.
- Acquaintance with oncology.
- Past involvement in operationally monitoring global teams.
- Former involvement in vendor oversight which involves CRO management.
- Acquaintance with assuming full responsibility for trial leadership.
- Works well with others as the trial manager and is passionate about oncology research.
- Previous involvement handling both early and late phase trials.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.
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