Position Summary
The Senior Clinical Trial Manager is responsible for the strategic planning, execution, oversight, and successful delivery of global clinical trials and programs. The role provides leadership across multiple studies, manages vendors and CROs, oversees budgets, drives operational excellence, and ensures compliance with global regulatory requirements.
This position plays a key leadership role within Global Clinical Operations and collaborates with cross-functional teams to ensure clinical trials are completed on time, within budget, and with the highest quality standards.
Key Responsibilities
Project Management & Trial Leadership
Lead global clinical trial planning, execution, and oversight.
Ensure studies meet timelines, budget targets, and quality standards.
Provide strategic input into study feasibility and operational planning.
Develop and implement trial execution strategies.
Lead cross-functional global study teams.
Drive study delivery from start-up through close-out.
Risk Management & Quality Oversight
Identify operational risks and develop mitigation plans.
Balance cost, quality, timelines, and operational priorities.
Monitor study performance metrics and KPIs.
Ensure compliance with:
ICH-GCP Guidelines
GXP Standards
Regulatory Requirements
Internal SOPs
Maintain audit and inspection readiness.
Vendor & CRO Management
Manage CROs and external vendor relationships.
Participate in vendor selection and evaluation.
Oversee Statements of Work (SOW).
Review and approve:
Vendor invoices
Budget accruals
Scope amendments
Change orders
Ensure vendor performance aligns with contractual obligations.
Strategic Study Guidance
Provide therapeutic and operational expertise.
Advise teams on protocol execution strategies.
Support study teams in operational decision-making.
Recommend improvements based on clinical operations trends.
Mentor and develop team members.
Budget & Resource Planning
Lead study budget planning and forecasting.
Conduct quarterly budget reviews.
Monitor financial performance and study expenditures.
Partner with Finance on forecasting and variance analysis.
Manage resource allocation and vendor logistics.
Program & Portfolio Oversight
Oversee multiple global clinical trials simultaneously.
Ensure alignment with franchise and development strategies.
Monitor operational performance across programs.
Drive continuous process improvements.
Support portfolio-level operational initiatives.
Clinical Systems & Data Management
Maintain study records in:
Veeva CTMS
Veeva eTMF
Clinical Trial Management Systems
Ensure data quality and system compliance.
Utilize operational metrics to support strategic decisions.
Required Qualifications
Education
Bachelor's Degree (BA/BS) in:
Life Sciences
Pharmacy
Biotechnology
Clinical Research
Healthcare-related discipline
Advanced degree preferred.
Experience
Required
Minimum 7 years of Clinical Operations experience.
Experience leading complex global clinical trials.
Experience within multinational pharmaceutical, biotech, or healthcare organizations.
Experience leading global and cross-functional teams.
Strong understanding of study and program strategy.
Preferred
CRO management experience.
Program-level clinical leadership experience.
Multi-study oversight experience.
Technical Competencies
Global Trial Management
Global Study Planning
Clinical Trial Execution
Study Lifecycle Management
Program Oversight
Clinical Operations
Site Management
Recruitment Strategies
Vendor Oversight
Study Governance
Financial Management
Budget Planning
Forecasting
Accrual Management
Cost Optimization
Regulatory Expertise
ICH-GCP
GXP
Regulatory Inspections
Audit Readiness
Systems Knowledge
Veeva CTMS
Veeva eTMF
Clinical Trial Systems
Operational Reporting Tools
Leadership Competencies
Leadership & Collaboration
Lead matrixed global teams.
Influence stakeholders across functions.
Build high-performing teams.
Strategic Thinking
Drive operational excellence.
Align study execution with business goals.
Decision Making
Resolve complex operational challenges.
Make data-driven decisions.
Communication
Present to senior leadership.
Manage global stakeholder relationships.
Drive alignment across teams.
Adaptability
Lead through organizational change.
Maintain team engagement during challenges.
Travel Requirement
Up to 25% domestic and international travel.
Career Progression
Potential future roles include:
Global Trial Lead (GTL)
Associate Director, Clinical Operations
Director, Clinical Operations
Program Director
Development Operations Lead
Executive Director, Clinical Development Operations
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
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Tuscaloosa |D.C :
Washington |Delaware :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
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Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
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Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
North York | Australia | Mississauga | Uxbridge | Richmond Hill | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
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