Senior Manager, Global Clinical Affairs Data (Hybrid - Acton, MA)

Job Summary

The Senior Clinical Data Manager is responsible for leading all aspects of the clinical data management lifecycle across multiple pre- and post-market studies, ensuring data integrity, regulatory compliance, and high-quality study execution. This role oversees EDC database design and validation, CRF development, data review, query management, database lock activities, and study closeout, while collaborating closely with cross-functional clinical teams. The position also drives process improvements, develops study metrics and tracking tools, supports investigator training, and serves as a subject matter expert on clinical data management best practices. The ideal candidate brings 6+ years of clinical data management experience, strong knowledge of GCP, FDA, HIPAA, GDPR, ISO, and 21 CFR Part 11 requirements, proficiency with multiple EDC platforms, and the ability to independently manage multiple priorities in a fast-paced environment.

Position Overview:

The Senior Clinical Data Manager is skilled in clinical data and systems management with demonstrated capability in coordinating activities across multiple studies. The Senior Clinical Data Manager contributes to process improvements and initiatives within the department and participates in all aspects of the clinical data management lifecycle.

Responsibilities:

• Understand the device data collected as part of clinical studies (pre and post market) and manage the data ensuring compliance with protocol, regulatory, GDPR and HIPAA
• Create and/or review study-specific Case Report Forms (CRFs) using prior device knowledge and protocol specific information. Work efficiently to incorporate clinical team input.
• As applicable, develop Case Report Form Library of common forms that can be used consistently across studies. 
• Develop, build, and configure EDC databases.
• Coordinate the validation and User Acceptance Testing (UAT) of EDC databases.
• Develop and/or Review study-specific data management and database documentation, which may include Data Management Plan (DMP), CRF Completion Guidelines (CCGs), Annotated CRFs, Edit/Logic Check Specifications, and UAT Plans.
• Collaborate with clinical team members to generate data review guidelines and perform data review and query generation/closure.
• Prepare data for scheduled snapshots/database locks.
• Perform appropriate database maintenance and closure and archival activities upon study completion.
• Provide data management expertise and support to clinical colleagues using data management best practices.
• Develops and provides study tracking and metrics tools to improve monitoring of study progress and data quality.
• Collaborate with clinical colleagues to train Investigators and Coordinators on the EDC system, and the CRF completion guidelines as needed.
• Identify improvements related to Clinical processes. As applicable, participate in development of a new process or revision of an existing process.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

Education and Experience

• Bachelor’s degree and/or an equivalent combination of education or experience
• Minimum of 6+ years of clinical data and/or systems experience
• Strong computer skills with a proficiency with MS Windows based applications
• Working knowledge of FDA regulations, Good Clinical Practices (GCP), and current industry practices related to the conduct of clinical trials this includes applicable ISO regulations for any trials conducted globally

Preferred Skills and Competencies:

• Able to prioritize workload, assign realistic completion dates, and complete assignments on schedule.
• Excellent written and oral communications skills required.
• Comfortable with multiple Electronic Data Capture (EDC) Systems
• Working knowledge of Good Clinical Practices (GCP), ISO, FDA regulations including 21 CFR part 11, and current industry practices related to the conduct of clinical trials, developing databases and managing protected health information.
• Strong organizational skills and attention to detail.
• Ability to work independently and manage multiple tasks in a fast-paced, changing environment.

Travel Requirements:

• This position requires some travel up to 5% of the time.

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $147,000.00 - $220,500.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.