Hobson Prior are working closely with a large pharmaceutical who are seeking a seasoned Global Study Manager on a contract basis located in Macclesfield. Our Client is focused on achieving real innovation and enhancing access to medicines.

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

Key Responsibilities:

• For this role, you will Oversee the study in partnership with the team, other clinical experts, and external service providers.
• Provide input into the preparation of delegated study documents (e.g., Informed Consent Form, Master Clinical Study Agreement, etc.) and external service provider documents (specifications, study-specific procedures, descriptions, presentations).
• Ensure efficient study delivery to time, cost, and quality objectives by maintaining and facilitating interactions with internal functions and external functions, including CROs.
• Plan and conduct internal and external meetings (e.g., Investigators'/Monitors' meetings).
• Liaise with Clinical Supply Chain or external service providers as necessary to ensure supply of investigational products.
• Actively contribute to the identification and mitigation of risks and issues, and the development of action plans.
• Verify the quality of all study documents within GSM's scope of responsibilities.
• Manage budgets, such as reconciling invoices from external service providers.
• Ensure study compliance with global clinical processes, procedural documents, applicable Quality & Compliance manuals, and international guidelines such as ICH/GCP.
• Providing overall project management support to the GSD and/or GSAD.
• Maintain the appropriate level of oversight of the CRO throughout the study lifecycle, in accordance with Company SOPs and guidelines (e.g., descriptions of services and transfer of obligations) for outsourced studies.
• Support GSD and/or GSAD in managing the CRO Project Manager to ensure study delivery in accordance with agreed timelines, budget and quality standards.
• Manage and oversee non-drug project work in process improvements and improvement projects as agreed with their manager

Key Skills:

• Ability to communicate effectively and build relationships, including managing external service providers.
• Ability to work independently and collaboratively.
• A proven ability to lead.
• Advanced computer skills for day-to-day tasks.
• Communication skills in English are excellent, both verbally and in writing.

Requirements:

• Degree in a medical or biological science (or a discipline associated with clinical research) (or the equivalent).
• Demonstrated experience within the pharmaceutical industry or similar organization.
• An understanding of the clinical development / drug development process in various phases of development and therapy.
• Extensive knowledge of international guidelines, including ICH/GCP
• A good understanding of project management is essential

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.