Hobson Prior is seeking a Study Management Associate to join a multinational pharmaceutical and biopharmaceutical company. The role is based in Cambridgeshire and you will be responsible for assisting associate directors study management and study management leads in fulfilling their accountabilities.
Study Management Associate – Cambridgeshire
- Develop study documents, and make amendments and updates to existing documents as necessary
- Prepare country-specific agreements (SMA), confidentiality agreements, clinical trial applications and other applicable country documents
- Monitor the supply of study materials and investigational products by liaising with Investigational Product Supply or external service providers
- Aid in the review or new/amended/unique SOPs and guidance documents
- Implement audits and regulatory inspections to support the study delivery team
- Maintain and close the TMF, whilst ensuring continual inspection readiness
- Great communication, negotiation, collaboration and interpersonal skills
- Able to manage change and champion more efficient and effective methods/processes
- Can manage multiple deliveries simultaneously
- Works flexibly in a team, and efficiently independently
- Degree in a related discipline – preferably in medical or biological science, or a discipline associated with clinical research
- Proven knowledge of ICH-GCP and basic knowledge of GMP/GDP
- Thorough understanding of the drug development process, study management and data management
- Fluency in the English language
- Experience working with and delivering through strategic partners and 3rd party vendors
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 specialist life science 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.