Global Study Lead – FSP

This is a fully remote position, open to applicants in India.

📋 Description

• Leadership of overall study initiatives.

• Manage the daily operations of the global clinical study.

• Direct cross-functional study teams including clinical operations, data management, biostatistics, medical monitoring, regulatory, supply chain, and safety.

• Ensure coherence between global strategies and regional implementations.

• Propel study timelines, key milestones, and deliverables.

• Create and uphold study timelines, operational plans, risk management plans, and enrollment strategies.

• Supervise country start-up, site activation, recruitment, monitoring, and closeout processes.

• Guarantee global consistency in protocol execution.

• Manage external vendors and clinical research organization (CRO) partners.

• Monitor performance metrics and quality of service.

• Address operational challenges and escalations.

• Oversee study budgets and financial forecasts.

• Recognize resource deficiencies and operational threats.

• Facilitate financial governance and manage changes.

• Identify study risks proactively.

• Lead efforts in mitigation and contingency planning.

• Ensure that study conduct adheres to ICH-GCP, local regulations, SOPs, and protocol requirements.

• Act as the primary operational contact for the study.

• Relay updates to senior leadership, study teams, regional teams, and sponsors/partners.

• Track enrollment, data cleaning, query resolution, and readiness for database lock.

• Ensure timely provision of high-quality data.

• Make operational decisions that influence study outcomes.

• Suggest process enhancements and efficiencies.

⛳️ Requirements

• Bachelor's degree in life sciences or a related field.

• A minimum of 15 years of relevant global study management experience.

• Extensive expertise in clinical research encompassing study management, monitoring, and data management.

• Proven experience in Oncology is required.

• Must have comprehensive experience in global clinical study management from feasibility to clinical study report (CSR), covering regions such as NA, EMEA, APAC, LATAM, and including China, Japan, and Africa as an advantage.

• Demonstrated experience in Ph II and Ph III studies; Ph I and Ph IV experience is a plus.

• Proven leadership experience in cross-functional settings, capable of steering both internal and external meetings.

• Strong background in clinical budget management.

• Significant experience in vendor management, including working with CROs.

• Familiarity with regulatory authority inspections (FDA, EMA, MHRA, PMDA, etc.) and involvement in studies critical for drug file registration is advantageous.

• Fluent in English, able to negotiate and discuss complex topics effectively with any clinical team member.

• Exceptional stakeholder management and communication skills, both oral and written, along with outstanding interpersonal abilities.

🏝️ Benefits

• Health insurance

• 401(k) matching