Senior Clinical Study Lead (Remote)

Takeda; United States; Remote; USD 116,000 - 182,000; Full time

Job summary

Takeda is seeking a Lead Clinical Study Manager to drive study strategy and oversee execution of clinical trials from a remote Massachusetts base. You will partner with Clinical Operations and global teams to ensure compliance with ICH GCP and local regulations while managing budgets and external vendors.

The role requires 6+ years in pharma/ CRO with substantial study management experience, strong leadership, and excellent communication.

Qualifications

• BS/BA in health-related or life science or technology fields.
• 6+ years in pharma/ CRO with 4+ years in study management/oversight.
• Fluent business English (oral and written).
• Knowledge of global regulatory requirements (ICH GCP, CFR, EU CTD).

Responsibilities

• Lead operation strategy and planning for assigned clinical trials.
• Oversee budget, timelines, and external spend with Finance and Program Leaders.
• Manage CROs/Strategic Partners and vendor relationships.
• Ensure studies meet quality standards and inspection readiness.
• Mentor and onboard junior Clinical Study Managers and team members.

Skills

Operational leadership

Budget management

Vendor management

Cross-functional collaboration

Communication skills

Project management

English fluency

Education

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

Advanced degree (MS/PhD) optional

Job description

Takeda is seeking a Lead Clinical Study Manager to drive study strategy and oversee execution of clinical trials from a remote Massachusetts base. You will partner with Clinical Operations and global teams to ensure compliance with ICH GCP and local regulations while managing budgets and external vendors.

The role requires 6+ years in pharma/ CRO with substantial study management experience, strong leadership, and excellent communication.