Local Study Manager (home-based)
5 days left
- Experience Level
Hobson Prior currently having an exciting opportunity for 2 Local Study Manager's to join a leading pharmaceutical organisation who provide pioneering medicines to patients all over the world. This is a contract position where you will be home-based.
- Overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
- Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
- Leads and optimises the performance of the Local Study Teams at country level ensuring compliance with the organisation's Procedural Documents, ICH-GCP and local regulations.
- Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
- Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in the organisation's clinical studies financial system by regular checks of the system and financial reports (as agreed with ADSMM/CH).
- Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
- Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations.
- Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol.
- Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
- Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
- Any other assigned duties.
- Have the capability to prioritise and handle multiple tasks.
- Exceptional attention to details.
- Have excellent knowledge of spoken and written English.
- Require's a bachelor's degree in life science, or equivalent qualification.
- At least 3 years of experience in Development Operations or other related fields.
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
- Oncology experience is essential.
- Previous experience as a CRA is essential.
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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