JOB DESCRIPTION

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)

Global Study Lead (FSP)

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