An excellent contract opportunity has arisen at a world-wide pharmaceutical organisation who provide pioneering medicines to patients. Our client is looking for a Global Study Manager (GSM) to join them in Cambridge.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Manage the set-up of third-party vendors, assessing initial statement of work and budget, as well as the change order process.
• To contribute to the development of study documents as appropriate as well as any updates, ensuring template and version compliance.
• You will assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates.
• To support the preparation of country specific agreements, confidentiality agreements, clinical trial applications and other applicable country documents.
• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.
• Support risk management and quality efforts to ensure study compliance.
• Support set-up, maintenance, closeout and archiving of the Trial Master File, ensuring continual inspection readiness.
• Prepare presentation material for meetings, newsletters and websites.
• Support the study team in the implementation of audits and regulatory inspections.
• To contribute to review of new/amended/unique SOPs and guidance documents.
• Provide input to data management documents, and interface with data management representatives and sites to facilitate the delivery of study data.
• Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
• Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
• Interface with third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.

Key Skills:

• Ability to coordinate and prioritise multiple tasks and deliverables.
• Demonstrated verbal and written communication skills.
• Good negotiation and collaboration skills.
• Demonstrated interpersonal and problem-solving skills.

Requirements:

• University degree / Bachelor's degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience.
• At least 2-3 years clinical trial experience.
• Experience of working with and delivering through strategic partners and 3rd party vendors.
• Excellent knowledge of ICH-GCP principles.

Apply now:

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.