Insulet Corporation

Insulet Corporation

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

Acton, Massachusetts, USA · Senior

Sponsorship not specified$147k-$221kDetected 7 hours 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.

Responsibilities

  • 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.

Requirements

  • Strong computer skills with a proficiency with MS Windows based applications

Nice to have

  • Preferred Skills and Competencies:

Skills

  • 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

  • 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

Company info

  • 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.
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