Study Manager - Clinical Trials
Posted Today by Unity Systems
Negotiable
Inside
Hybrid
England, United Kingdom
Summary: The Global Study Asset Manager is responsible for overseeing global clinical operations delivery across multiple studies within a specific asset portfolio. This role requires end-to-end study execution, ensuring compliance with regulatory standards and alignment with timelines and budgets. The GSAM will collaborate with various stakeholders, including Global Study Leaders and CROs, to ensure efficient study delivery. The position is a senior operational lead role, requiring significant experience in global clinical operations.
Key Responsibilities:
- Lead global clinical operations execution for multiple studies within an asset portfolio
- Own operational delivery across the full study lifecycle from set-up through close-out
- Ensure compliance with ICH-GCP, regulatory requirements, SOPs, and internal processes
- Act as a core member of global study teams, providing operational leadership and consistency
- Partner with CROs to ensure high-quality delivery, clear accountability, and cost efficiency
- Lead CRO and vendor lifecycle management, including selection, contracting support, oversight, performance monitoring, and close-out
- Define, track, and report operational and quality KPIs, ensuring timely and accurate system data
- Proactively identify risks to timelines, quality, or compliance and implement mitigation plans
- Maintain inspection readiness through strong documentation discipline and oversight
- Contribute to and review essential study documents including protocols, trial management plans, pharmacy manuals, study plans, and training materials
- Develop and maintain recruitment forecasts and enrolment plans in collaboration with analytics teams, countries, and CRO partners
- Oversee IMP supply, logistics, and distribution, ensuring continuity and regulatory compliance
- Manage patient- and site-facing materials, including production, translation, and distribution
- Coordinate clinical trial insurance activities as required
- Collaborate closely with Global Study Leaders, operations leaders, and cross-functional teams
- Build strong, trust-based relationships with CRO study management teams
- Ensure transparent communication of study performance, risks, and vendor issues
- Escalate issues appropriately and support resolution through structured governance
Key Skills:
- University degree (life sciences preferred) or equivalent relevant experience
- Minimum 3 years’ experience in global clinical operations or study management
- Proven experience coordinating multiple global studies or an asset-level portfolio
- Strong applied knowledge of ICH-GCP and global regulatory requirements
- Demonstrated experience managing CROs and third-party vendors
- Experience developing or contributing to core study documentation
- Strong understanding of forecasting, KPIs, systems-based tracking, and inspection readiness
- Highly organised, detail-focused, and comfortable working across complex global matrices
Salary (Rate): undetermined
City: Welwyn Garden City
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: inside IR35
Seniority Level: undetermined
Industry: Other
Global Study Asset Manager – Global Clinical Operations (Contract) Contract: Full-time, 6-month contract Start: February 2026 Location: Welwyn Garden City, UK (hybrid – minimum 2 days onsite per week) IR35: Inside IR35 Right to Work: UK RTW required (no sponsorship)
Role Summary We are hiring an experienced Global Study Asset Manager (GSAM) to take ownership of global clinical operations delivery across a portfolio of studies within a molecule or asset. This role is responsible for end-to-end study execution , ensuring delivery is compliant, inspection-ready, and aligned to timelines, quality standards, and budget expectations. The GSAM operates as a senior operational lead within global study teams, partnering with Global Study Leaders, CROs, country teams, and cross-functional stakeholders to drive efficient and consistent study delivery across regions.
Key Responsibilities
- Lead global clinical operations execution for multiple studies within an asset portfolio
- Own operational delivery across the full study lifecycle from set-up through close-out
- Ensure compliance with ICH-GCP, regulatory requirements, SOPs, and internal processes
- Act as a core member of global study teams, providing operational leadership and consistency
- Partner with CROs to ensure high-quality delivery, clear accountability, and cost efficiency
- Lead CRO and vendor lifecycle management , including selection, contracting support, oversight, performance monitoring, and close-out
- Define, track, and report operational and quality KPIs , ensuring timely and accurate system data
- Proactively identify risks to timelines, quality, or compliance and implement mitigation plans
- Maintain inspection readiness through strong documentation discipline and oversight
- Contribute to and review essential study documents including protocols, trial management plans, pharmacy manuals, study plans, and training materials
- Develop and maintain recruitment forecasts and enrolment plans in collaboration with analytics teams, countries, and CRO partners
- Oversee IMP supply, logistics, and distribution , ensuring continuity and regulatory compliance
- Manage patient- and site-facing materials , including production, translation, and distribution
- Coordinate clinical trial insurance activities as required
- Stakeholder & Partner Engagement
- Collaborate closely with Global Study Leaders, operations leaders, and cross-functional teams
- Build strong, trust-based relationships with CRO study management teams
- Ensure transparent communication of study performance, risks, and vendor issues
- Escalate issues appropriately and support resolution through structured governance
Essential Experience & Qualifications
- University degree (life sciences preferred) or equivalent relevant experience
- Minimum 3 years’ experience in global clinical operations or study management
- Proven experience coordinating multiple global studies or an asset-level portfolio
- Strong applied knowledge of ICH-GCP and global regulatory requirements
- Demonstrated experience managing CROs and third-party vendors
- Experience developing or contributing to core study documentation
- Strong understanding of forecasting, KPIs, systems-based tracking, and inspection readiness
- Highly organised, detail-focused, and comfortable working across complex global matrices
Desirable Experience
- Direct clinical trial management experience in global development programmes
- Background within large pharma or global CRO environments
- Familiarity with clinical operations planning, forecasting, and issue-tracking systems
- Continuous improvement mindset with a focus on quality and efficiency
Ideal Candidate Profile
- A hands-on global clinical operations leader who can independently run operational delivery
- Confident managing CROs, vendors, and multiple stakeholders in parallel
- Structured, systems-driven, and inspection-ready in approach
- Comfortable operating in fast-paced, ambiguous, and highly collaborative environments
Not Suitable For
- Candidates limited to site-level or local operations roles
- Profiles without evidence of global study or asset-level ownership
- Candidates lacking meaningful CRO/vendor oversight or inspection readiness experience