Global Study Manager

2 weeks ago


Cambridge, United Kingdom Hays Specialist Recruitment Limited Full time

Experienced Clinical GSM for Early Phase Oncology Studies, 12 month rolling contract
- Perform study management tasks as per agreed delegation by the Global study Associate Director/Director
- In partnership with internal specialists and external service providers, provide oversight (as delegated) to ensure study delivery of both internally-run and outsourced studies.
- Lead/contribute to the preparation of study documents (e.g. Informed Consent Form, applicable study plans, etc.), and external service provider-related documents (e.g. specifications, study specific procedures, etc.)
- Maintain and facilitate interactions with functions to ensure efficient study delivery to time, costs and quality objectives.
- Lead the set-up and maintenance of third-party vendors.
- Proactively contribute to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.

Crucial requirements:

- Relevant pharmaceutical industry and/or clinical trial experience (ideally at least 3-4 years)
- Deep understanding of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development
- Validated organizational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
- Proven ability to work well both on a cross-functional team and independently
- Strong collaborative communication skills (verbal & written) in English
- Ability to prioritise appropriately and to be adaptable
- Demonstrated leadership skills
- Computer proficiency in day-to-day tasks

Desirable requirements:

- Experience in external service provider management
- Experience in all phases of a clinical study lifecycle
- Demonstrated project management skills



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