Global Study Lead - FSP

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Global Study Lead – This position is a fully client-embedded role, dedicated to a leading bio-pharma company.

Role Purpose:

This GSL is a single accountable person and a Clinical Operations representative. Will drive operational strategy, planning and leading the study and being aligned with the asset strategy. The GSL and GSM work s a leadership-operational duo.
 

Key Responsibilities:

1. Overall Study Leadership

• Own the day-to-day management of the global clinical study
• Lead cross-functional study teams (clinical operations, data management, biostatistics, medical monitoring, regulatory, supply chain, safety, etc.)
• Ensure alignment between global strategy and regional execution
• Drive study timelines, milestones, and deliverables
   

2. Study Planning and Execution

• Develop and maintain:
  • study timelines
  • operational plans
  • risk management plans
  • enrollment strategies
     
• Oversee country start-up, site activation, recruitment, monitoring, and closeout
• Ensure protocol execution is consistent globally
   

3. Vendor and CRO Oversight

• Manage external vendors and CRO partners
• Track performance metrics and service quality
• Resolve operational issues and escalations
• Ensure vendors meet contractual obligations and timelines

4. Budget and Resource Management

• Monitor study budgets and forecasts
• Track study spend against plan
• Identify resource gaps and operational risks
• Support financial governance and change management
   

5. Risk and Issue Management

• Identify study risks early
• Lead mitigation and contingency planning
• Handle escalations related to:
  • recruitment delays
  • protocol deviations
  • data quality issues
  • supply shortages
  • inspection readiness
     

6. Regulatory and Quality Compliance

• Ensure study conduct follows:
  • ICH-GCP
  • local regulations
  • SOPs
  • protocol requirements
     
• Support inspection readiness and audit activities
• Oversee CAPAs when needed
   

7. Cross-Functional Communication

• Serve as the central operational contact for the study
• Communicate updates to:
  • senior leadership
  • study teams
  • regional teams
  • sponsors/partners
• Lead governance meetings and study reviews
   

8. Data and Study Oversight

• Monitor enrollment, data cleaning, query resolution, and database lock readiness
• Review KPIs and operational metrics
• Ensure timely delivery of quality data
   

9. Strategic Decision-Making

• Make operational decisions that impact study delivery
• Balance quality, speed, cost, and patient safety
• Recommend process improvements and efficiencies

Education Requirements:

- Bachelor’s degree: life sciences or related discipline; The role will require a good understanding of complex clinical development and regulatory processes.

Role Related Experience:

• At least 15+ years of relevant study management experience on a global level.
• In-depth experience in clinical research: study management, monitoring, data management
• Previous in-depth Oncology experience
• Must have exposed to clinical study management “end-to-end” Globally : NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset –
• Must have proven experience from study feasibility to CSR
• Must have at least Ph II and PIII experience – PI & PIV is an asset
• Must have cross-functional leadership proven experience, able to drive internal and external meeting
• Able to input in clinical protocol, ICF, and other study plan, savvy in clinical study risk management and clinical systems
• Strong experience in clinical budget management
• Strong experience with vendor management including CRO
• Exposed to competent authority Inspections (FDA, EMA, MHRA, PMDA...), being involved in studies pivotal for drug file registration is an asset
• Fluent in English, to the level they can negotiate and discuss (adapt message) related to complex topics with any Clinical team member (Local country representative, Statistician, Data Manager, laboratory, central laboratory, Scientific writer, safety representative, study Phycician and any type of vendors as well as able to present clear status to upper management if required.
• Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.
• Demonstrates leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
• Strong understanding of the clinical study, drug development, sample management and other associated process and quality requirements, including ICH/GCP guidelines and SOPs
• Good project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available)