Global Study Manager (GSM)

Job Description / Capsule

The GSM supports delivery of global clinical studies from study set-up through maintenance, close-out and study archiving. The GSM works cross-functionally with internal and external partners to lead & deliver aspects of the clinical study in accordance with Senior Global Study Leader (SrGSL) or Global Study Leader (GSL) delegation, applicable clinical trial regulations (ex. ICH-GCP), Standard Operating Procedures (SOPs), policies & best practices and values & behaviours.

Typical Accountabilities

• Perform study management tasks as per agreed delegation/oversight by SrGSL/GSL.
• In partnership with internal experts and external service providers, provide oversight (as delegated by the SrGSL/GSL) 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).
• Adhere to SOPs, global process, applicable Quality & Compliance manual documents and international guidelines (e.g. ICH-GCP) to ensure study is inspection ready at all times.
• 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.

Education, Qualifications, Skills and Experience

Essential

• University degree (or equivalent educational/work experience), preferably in medical or biological sciences or discipline associated with clinical research.
• At least 12 months relevant pharmaceutical industry and/or clinical trial experience, in a clinical project management role.
• Early Oncology experience (though transferrable early development experience from other TAs may be accepted for the right candidate)
• Experienced working as part of the global study team
• Solid knowledge of the nuances of Phase 1 & 2 and the speed of execution required
• Vendor management experience
• Strong soft skills: collaboration / partnering cross functionally; teamwork; influencing
• Experience of working in big pharma environment a plus
• Deep understanding of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development.
• Proven organizational, 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
• Ability to prioritize appropriately and to be adaptable
• Demonstrated leadership skills

Desirable

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

Key Relationships to reach solutions

Internal

• Senior Global Study Leader, Global Study Leader, Global Study Associate
• Associate Director Study Operations
• Study Management Early group
• Early RIA & Early CVRM groups
• Study Physician
• Statistics, Programming & Data Management
• Global Regulatory Affairs
• Patient Safety
• Procurement
• Quality Assurance
• Supply Chain
• Other Development Operations functions (ex. Site Management & Monitoring, Enablement, Clinical Trial Transparency, etc.)
• Other functional representatives in the study team

External

External service providers (ex. CRO, suppliers, etc)