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.
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