Remote Lead Clinical Study Manager — Strategy & Execution

Takeda Pharmaceutical Co.; Boston (MA); Remote; USD 116,000 - 182,000; Full time

Job summary

Takeda Pharmaceutical Co. seeks a Lead Clinical Study Manager to join remotely and report to the Clinical Operations Leadership team.

You will lead study operational strategy, oversee execution, manage CROs and vendors, and ensure regulatory compliance within schedule and budget while supporting cross-functional partners across global programs. You will influence budgeting, timelines, and risk management, ensuring study readiness and effective onboarding of new team members, with travel as

Qualifications

• Fluent business English (oral and written).
• Excellent communication and teamwork skills.
• Strong project management and matrix leadership capabilities.
• Experience with regulatory compliance and global clinical trials.

Responsibilities

• Lead study operational strategy and planning for assigned clinical programs.
• Oversee execution of studies in compliance with ICH GCP and Takeda SOPs, on schedule and budget.
• Manage CROs/strategic partners and vendor relationships; budget governance and contracting.
• Ensure study readiness for inspections and provide onboarding for new team members.

Skills

Fluent business English

Excellent communication skills

Excellent teamwork

Project management

Problem-solving

Leadership

Education

BS/BA in health-related or life science or tech fields

Advanced degree (MS/PhD/MD)

Job description

Takeda Pharmaceutical Co. seeks a Lead Clinical Study Manager to join remotely and report to the Clinical Operations Leadership team.

You will lead study operational strategy, oversee execution, manage CROs and vendors, and ensure regulatory compliance within schedule and budget while supporting cross-functional partners across global programs. You will influence budgeting, timelines, and risk management, ensuring study readiness and effective onboarding of new team members, with travel as