Global Study Lead - FSP

Work Schedule
Standard (Mon-Fri) Environmental Conditions
Office Job Description
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

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Own the day-to-day management of the global clinical study

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Lead cross-functional study teams (clinical operations, data management, biostatistics, medical monitoring, regulatory, supply chain, safety, etc.)

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Ensure alignment between global strategy and regional execution

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Drive study timelines, milestones, and deliverables

2. Study Planning and Execution

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Develop and maintain:

- study timelines

- operational plans

- risk management plans

- enrollment strategies

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Oversee country start-up, site activation, recruitment, monitoring, and closeout

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Ensure protocol execution is consistent globally

3. Vendor and CRO Oversight

- Manage external vendors and CRO partners

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Track performance metrics and service quality

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Resolve operational issues and escalations

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Ensure vendors meet contractual obligations and timelines

4. Budget and Resource Management

- Monitor study budgets and forecasts

- Track study spend against plan

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Identify resource gaps and operational risks

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Support financial governance and change management

5. Risk and Issue Management

- Identify study risks early

- Lead mitigation and contingency planning

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Handle escalations related to:

- recruitment delays

- protocol deviations

- data quality issues

- supply shortages

- inspection readiness

6. Regulatory and Quality Compliance

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Ensure study conduct follows:

- ICH-GCP

- local regulations

- SOPs

- protocol requirements

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Support inspection readiness and audit activities

- Oversee CAPAs when needed

7. Cross-Functional Communication

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Serve as the central operational contact for the study

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Communicate updates to:

- senior leadership

- study teams

- regional teams

- sponsors/partners

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Lead governance meetings and study reviews

8. Data and Study Oversight

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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

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Make operational decisions that impact study delivery

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Balance quality, speed, cost, and patient safety

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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:

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At least 6+ years of relevant study management experience on a global level .

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In-depth experience in clinical research: study management, monitoring, data management

- Previous in-depth Oncology experience

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Must have exposed to clinical study management “end-to-end” Globally : NA, EMEA, APAC, LATAM – China & Japan, Africa is an asset –

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Must have proven experience from study feasibility to CSR

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Must have at least Ph II and PIII experience – PI & PIV is an asset

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Must have cross-functional leadership proven experience, able to drive internal and external meeting

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Able to input in clinical protocol, ICF, and other study plan, savvy in clinical study risk management and clinical systems

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Strong experience in clinical budget management

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Strong experience with vendor management including CRO

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Exposed to competent authority Inspections (FDA, EMA, MHRA, PMDA...), being involved in studies pivotal for drug file registration is an asset

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Fluent in English, to the level they can negotiate and discuss (adapt message) related to complex t