Global Clinical Study Manager

A vacancy has become available for a Global Clinical Study Manager, this is a home-based role at a large pharmaceutical organisation. You will be expected to work cross functionally to ensure study delivery.

Job Responsibilities

• In partnership with internal experts and external service providers, provide oversight to ensure study delivery of both internally-run and outsourced studies.
• Lead/contribute to the preparation of delegated 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 both internal & external functions to ensure efficient study delivery to time, costs and quality objectives.
• Manage the set-up and maintenance of third-party vendors.
• Support the SrGSL/GSL with budget management. Initiate contract/budget requests for third-party vendors, facilitate generation of purchase orders, track spend against approved budget and manage the change order process.
• Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
• Contribute to the planning and conduct of internal and external meetings.
• Ensure adequate supply of study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
• Proactively contribute to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
• Ensure that all study documents within scope of the GSM's responsibilities are complete and verified for quality in the Trial Master File (TMF).
• Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their line manager. May act as Subject Matter Expert for a particular process or system within Study Management Early.

Skills and Requirements

• University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research.
• Relevant pharmaceutical industry and/or clinical trial experience.
• Deep understanding of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development.
• Proven organisational, time management & analytical skills; excellent attention to detail and ability to multi-task in a fast-paced and dynamic environment
• Demonstrated 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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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