Senior / Principal Clinical Data Manager

Responsibilities: 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 acceptable 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.

Requirements: A Bachelor or Master’s degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields. Minimum 3-5+ years of experience of Pharma/CRO industry experience with at least 1-3 years of data management experience Proficient knowledge of Medidata RAVE, Oracle InForm and/or IBM Clinical Development