Global Study Lead (FSP)

Job Title

Global Study Lead (FSP)

Job Location

Remote, India

Job Location Type

Remote

Job Contract Type

Full-time

Job Seniority Level

Work Schedule

Standard (Mon-Fri)Environmental Conditions

OfficeJob 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

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

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

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

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

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

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

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

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

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)

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Originally posted on Himalayas