Data Acquisition & Compliance Lead — Third-Party

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

Job summary

The role requires coordinating with cross-functional partners, ensuring compliance with ICH-GCP and regulatory standards, and mentoring a team of Managers and Coordinators to raise data quality.

This position is based in Boston and offers exposure to a broad clinical data ecosystem, including data from eCOA, labs, wearables, and imaging, with a focus on scalable processes.

Qualifications

• BS/BA in health-related or life sciences with 6+ years in drug development.
• Strong understanding of ICH-GCP and global regulatory requirements.
• Experience acquiring and overseeing external clinical data from third-party vendors.
• Excellent project management, organizational, and analytical skills.
• Ability to train and mentor TPDA team members.

Responsibilities

• Perform TPDA activities for studies to ensure compliance and audit readiness.
• Escalate and resolve study/program-level data issues with cross-functional teams.
• Monitor data deliverables to ensure consistency and standards adherence.
• Train and mentor Managers and Coordinators on TPDA processes.
• Collaborate on process improvements and departmental initiatives.
• Engage with external vendors to align on data transfer and timelines.

Skills

Project management

Cross-functional collaboration

Data governance

Mentoring

Education

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

Tools

Microsoft Office

TMF systems

Clinical data platforms

Job description

The role requires coordinating with cross-functional partners, ensuring compliance with ICH-GCP and regulatory standards, and mentoring a team of Managers and Coordinators to raise data quality.

This position is based in Boston and offers exposure to a broad clinical data ecosystem, including data from eCOA, labs, wearables, and imaging, with a focus on scalable processes.