Senior Global Clinical Study Lead (Remote)

Takeda; Boston (MA); On-site; USD 116,000 - 182,000; Full time

Job summary

Takeda is seeking a Lead Clinical Study Manager (Lead CSM) for Global Clinical Development Operations. This remote role supports global program strategy, oversees cross-functional study teams, and manages external partners to ensure timely, compliant trial execution.

Strong budget, risk management, and regulatory knowledge are essential. The role requires extensive clinical study management experience, with 4+ years in oversight, and fluency in business English.

Qualifications

• BS/BA in health-related or life science field or equivalent
• 6+ years in pharma/ CRO with 4+ years in study management/oversight
• Fluent business English (oral & written)
• Strong communication and teamwork skills
• Knowledge of US CFR, EU CTR, ICH GCP and local requirements

Responsibilities

• Lead cross-functional study execution teams to meet objectives
• Oversee external vendors and CROs to align with plans and budgets
• Manage study budgets, timelines, and risk mitigation
• Collaborate with Clinical Ops leaders to ensure alignment with development plans
• Prepare for inspections and ensure study readiness

Skills

Project management

Leadership

Communication

Teamwork and collaboration

Global/ Regulatory knowledge

Education

BS/BA in life sciences or related field

Advanced degree (MS/PhD)

Job description

Takeda is seeking a Lead Clinical Study Manager (Lead CSM) for Global Clinical Development Operations. This remote role supports global program strategy, oversees cross-functional study teams, and manages external partners to ensure timely, compliant trial execution.

Strong budget, risk management, and regulatory knowledge are essential. The role requires extensive clinical study management experience, with 4+ years in oversight, and fluency in business English.