Local Study Manager (field-based)
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Hobson Prior currently having an exciting opportunity for a Local Study Manager 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 field-based.
- You will be ensuring that clinical and operational feasibility assessment of potential studies is performed at the highest quality possible.
- To have the overall responsibility for the study commitments within the country, you will ensure that the delivery of the data is at a timely manner and at a required quality.
- You will organise the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment and conducting Site Qualification Visits to assess suitability and quality risks.
- You will manage and enhance the performance of the LST at country level ensuring compliance with organisations Procedural Documents, ICH-GCP and local regulations.
- Ensures timely submission of applications 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 and maintains accurate study budget in organisations clinical studies financial system by regular checks of the system and financial reports.
- You will manage the Local Study Team consisting of CRA, CSA, for allocated studies.
- To ensure timely preparation of local Master CSA and adjustments as needed.
- Ensures timely preparation of country level Master Informed Consent Form and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local 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.
- You will require 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.
€55000.00 - €70000.00 per annum
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