Hybrid Senior Manager, Global Clinical Affairs Data

Posted last month

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About the role

  • Manage data for all global studies including identifying sources of data, data collection, data processing, data flows, data privacy, data integrity, and data distribution.
  • Summarize data analysis and collaborate in writing a formal report for regulatory agencies.
  • Perform User Acceptance Testing of clinical databases.
  • Liaise with the biostatistician to ensure alignment on data collection and analysis.
  • Collaborate on study close-out activities and manage the database lock.
  • Ensure all adverse event documentation is sufficiently detailed to facilitate adjudication.
  • Collaborate cross-functionally to obtain all study data related to an adverse event and manage communication of adverse event reporting to the Medical Monitor or Data Safety Monitoring Board when applicable.
  • Manage the finalization of the report shell in collaboration with Medical Affairs.
  • Manage the distribution of data to clinical sites after study completion and manage data retention according to internal processes and regulations.
  • Define and manage internal data management processes and develop data management plans for all global studies.
  • Implement quality control checks, troubleshoot data issues, and perform other duties as required.

Requirements

  • Bachelor’s degree and/or an equivalent combination of education or experience.
  • Minimum of 10 years of relevant experience in the field.
  • Analytical skills, detail-oriented, and good interpersonal skills.
  • Knowledge of agency guidelines and requirements.
  • Excellent written and effective verbal communication skills.
  • Ability to communicate cross-functionally across the organization.
  • PC skills: word processing, spreadsheet, database, Internet search and utilization.
  • Flexible and able to work in a fast-paced environment.
  • Team player.
  • Ability to organize and judge priorities.
  • Excellent ability to generate and maintain accurate records.

Benefits

  • Eligible for hybrid working arrangements (requires on-site work from an Insulet office; may work remotely other days).
  • Competitive US base salary range provided (base only; compensation details do not include bonus, equity, or benefits).
  • Culture that supports a healthy work and life balance.
  • Professional development and learning opportunities.
  • Collaborative, global team environment and opportunity to work on innovative medical devices.

Job title

Senior Manager, Global Clinical Affairs Data

Job type

Experience level

Senior

Salary

$143,325 - $214,988 per year

Degree requirement

Bachelor's Degree

Location requirements

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