Clinical Trial Specialist

Global Study Asset Manager – Global Clinical Operations (Contract)

Contract Type: Full-time, 6-month contract

Start Date: February 2026

Location: Welwyn Garden City, UK (minimum 2 days per week onsite; hybrid working permitted)

IR35: Inside IR35

Right to Work: Must hold valid UK Right to Work (no sponsorship available)

We are seeking an experienced Global Study Asset Manager (GSAM) to lead and deliver global clinical operations across a portfolio of studies within a molecule or asset. This is a hands-on, delivery-focused role responsible for end-to-end operational study management , working in close partnership with global study leaders, cross-functional teams, and CRO partners. The GSAM provides operational leadership to ensure consistent, efficient, inspection-ready execution of global clinical studies in alignment with ICH-GCP , SOPs, and internal processes. The role is aligned to a UK hub and operates within a highly collaborative global environment.

Key Responsibilities

• Lead and coordinate global study management activities across multiple studies within an asset portfolio
• Ensure studies are delivered on time, within scope, and to quality , in compliance with ICH-GCP , SOPs, and regulatory requirements
• Partner closely with Global Study Leaders, Global Operations leaders, country teams, and CROs to drive operational execution
• Provide operational input into essential study documents, including protocols, trial management plans (TMPs), pharmacy manuals, study plans, and training materials
• Develop and maintain recruitment expectations and enrolment forecasts , collaborating with analytics teams, countries, and CRO partners, using appropriate forecasting systems
• Build strong, effective CRO partnerships , maximising efficiency, minimising duplication, and ensuring cost-effective delivery
• Define, track, and oversee operational and quality KPIs , ensuring accurate and timely data entry into clinical systems
• Proactively identify, communicate, and mitigate operational risks , escalating issues appropriately and maintaining transparency
• Maintain inspection readiness across all areas within scope through robust documentation and oversight
• Lead third-party vendor selection, set-up, oversight, and close-out , ensuring delivery to contract and alignment with integrated clinical operations strategies
• Oversee patient- and site-facing materials , including production, translation, and distribution
• Manage IMP supply, logistics, and shipment , ensuring continuity and compliance
• Coordinate clinical trial insurance activities as required
• Stakeholder & Vendor Management
• Act as a core member of the Extended Study Management Team , providing operational expertise and consistency across studies
• Collaborate with cross-functional partners including clinical development, regulatory, safety, data management, and quality
• Work closely with CRO study management teams to ensure high-quality, efficient delivery
• Escalate and document vendor or study performance issues appropriately, ensuring visibility and resolution

Essential Qualifications & Experience

• University degree (preferably in life sciences) or equivalent relevant experience
• Minimum 3 years’ experience in clinical operations or study management , ideally within global clinical trials
• Strong working knowledge of the drug development process and applicable regulations, including ICH-GCP
• Proven experience coordinating study management across multiple studies or an asset portfolio
• Demonstrated experience working with and overseeing CROs and third-party vendors
• Experience contributing to and maintaining core study documentation
• Strong understanding of recruitment forecasting, KPIs, operational oversight, and inspection readiness
• Highly organised, systems-driven, and detail-oriented, with strong problem-solving skills

Desirable Experience

• Direct global clinical trial management background (beyond site-level or local operations)
• Experience working within large pharma or global CRO environments
• Familiarity with clinical operations systems used for forecasting, issue tracking, and integrated planning
• Demonstrated continuous improvement mindset and ability to enhance quality and efficiency

Personal Attributes

• Self-starter with strong ownership mentality and minimal supervision required
• Confident operating in fast-paced, complex, and ambiguous environments
• Strong communicator with the ability to influence stakeholders and manage issues transparently
• Collaborative, pragmatic, and delivery-focused

Ideal Candidate Profile

• A hands-on global clinical operations professional capable of owning operational delivery across a portfolio of studies
• Experienced in CRO/vendor oversight , risk management, forecasting, and inspection readiness
• Comfortable partnering with senior study leaders while maintaining structure, documentation discipline, and system accuracy

Not Suitable For

• Candidates with only site-level or local operations experience
• Profiles lacking evidence of global study coordination or asset-level ownership
• Candidates without meaningful CRO/vendor oversight or inspection-ready delivery experience