Insulet Corporation

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

Acton, Massachusetts · Senior

Sponsorship not specified$147k-$221kDetected 8 days ago

GCPComplianceHIPAAClinical TrialsFDA RegulatoryMedical DevicesCommunicationOrganizational Skills

About the role

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.
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.

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.
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.
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.
Ability to work independently and manage multiple tasks in a fast-paced, changing environment.

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
Strong organizational skills and attention to detail.

Compensation & Benefits:For U.S.-based positions only, the annual base salary range for this role is $147,000.00 - $220,500.00This position may also be eligible for incentive compensation.We offer a comprehensive benefits package, including

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
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team.

This listing is sourced directly from Insulet Corporation's careers page and normalized into a canonical job model.