Director, Clinical Data Management - Global Trials

Kailera Therapeutics, Inc.; Waltham (MA); On-site; USD 196,000 - 240,000; Full time

Job summary

Kailera Therapeutics, Inc. in Waltham, MA is seeking an experienced Director, Data Management to lead data management deliverables across clinical trials.

This role reports to Head of Clinical Data Management and coordinates with study stakeholders to define a data strategy. Responsibilities include vendor oversight, program-level leadership, study-team collaboration, monitoring QA metrics, and ensuring TMF readiness.

Qualifications

• 10+ years of clinical data management experience in the pharmaceutical or biotechnology industry.
• Proven track record providing strategic data management leadership across late-stage development programs.
• Expert knowledge of clinical trial data management, including CDASH standards, database lock, external data reconciliation, inspection readiness, and adherence to regulatory guidelines.
• Deep expertise in global CRO oversight, vendor management, and strategic outsourcing models.
• Demonstrated experience with eTMF systems and the documentation requirements related to Data Management.
• Strong command of electronic data capture (EDC) systems and data warehousing technologies.

Responsibilities

• Lead vendor oversight activities across global development programs, ensuring alignment between Kailera and CROs on all data management deliverables.
• Provide program-level leadership and oversight of clinical data management activities; monitor and report on program and study progress.
• Represent the Data Management function on the study team, fostering cross-functional collaboration and clear expectations.
• Monitor vendor performance and quality metrics, elevate issues to management, and drive resolution strategies.
• Proactively identify risks and develop and implement mitigation or corrective action plans.
• Ensure Data Management Trial Master File (TMF) documentation is filed accurately and maintained in an inspection-ready state.
• Support study-level inspection readiness and audit preparation efforts.

Skills

Clinical data management

Vendor oversight

Regulatory compliance

CDASH standards

eTMF documentation

EDC systems

Data management leadership

Education

Bachelor's degree in Life Sciences

Tools

eTMF systems

EDC systems

Job description

Kailera Therapeutics, Inc. in Waltham, MA is seeking an experienced Director, Data Management to lead data management deliverables across clinical trials.

This role reports to Head of Clinical Data Management and coordinates with study stakeholders to define a data strategy. Responsibilities include vendor oversight, program-level leadership, study-team collaboration, monitoring QA metrics, and ensuring TMF readiness.