Principal Data Manager

Act as the primary contact person for communication and discussion of topics related to data management timelines and deliverables; requests for out-of-scope tasks; and first line contact for technical or procedural issues.

Perform hands-on data management tasks including, but not limited to, writing database design specifications, test plans for user acceptance testing (UAT), and data transfer specifications. When these tasks are assigned to Data Management support team members, the Principal Clinical Data Manager is responsible for review or to provide data management oversight and approvals for the task performed to ensure quality deliverable, including review of UAT plans to ensure accuracy and consistency among projects. Facilitate and participate in UAT, as necessary.

Review data, issue queries, and resolve queries from various data sources (e.g., medical coding, medical history, adverse events, procedures and medicinal products, and external data). Assist other Clinical Research Organizations, Sponsor, or Investigative Sites with resolving queries.

Perform third party non-Case Report Form data management activities.

Plan, manage, and perform data processing and data management activities for assigned projects to ensure tasks are performed in a timely manner and in compliance with trial Sponsors’ requirements.

Accurately and efficiently validate electronically captured data. Lead efforts in writing clear queries on missing data and data points failing pre-defined range checks and/or logical checks.

Validate and disseminate real-time study monitoring reports to Sponsor and internal team members.

Review database edit check specifications for assigned studies. Lead efforts in developing and maintaining standard database validation checks for common modules as well as for therapeutic/drug area specific modules.

Perform training on the electronic data capture (EDC) system, dataflow, and quality control (QC) processes to clinical trial personnel.

Participate in project kick off meetings, investigators meetings, and regular project management team meetings.

Perform study-level resource planning and management, including the review of team members’ timesheet reports.