Hobson Prior is working in a well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire a Study Management Associate. This vacancy is an exciting opportunity to work at a top global pharmaceutical company that has a workforce of more than 6,700 employees across multiple sites in the UK.
The Study Management Associate is accountable for assisting Associate Directors Study Management and Senior Study Management Associates fulfil their accountabilities through coordinating activities that ensure quality, consistency, and integration of study data and clinical trial processes and providing administrative support. The exact accountabilities will differ depending on the exact nature of the clinical programme, so a high degree of flexibility is required.
- Contribute to the development of study documents as appropriate as well as any updates/amendments to those documents
- Lead the preparation of country specific agreements (SMA), confidentiality agreements, clinical trial applications and other applicable country documents.
- Contribute to review of new/amended/unique SOPs and guidance documents
- Ensure the supply of study materials and Investigational product by liaising with Investigational Product Supply or external service providers as appropriate.
- Support the study delivery team in the implementation of audits and regulatory inspections
- Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timeline or budget objectives with the Associate Director Study Management.
- Interface with Investigators, third party vendors, Marketing Companies and internal staff to support effective delivery of a study and its regulatory documents through finalization of the protocol through to the Clinical Study Report (CSR) and administrative appendices
- Maintain and close the TMF, ensuring continual inspection readiness
- Initiate and maintain production of study documents, ensuring template and version compliance
- Provide input to data management documents (e.g. Case Report Form, Data Validation Specification), and interface with data management representatives and sites to facilitate the delivery of study data
- Prepare presentation material for meetings, newsletters and web-sites
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 science recruiter focussed 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.