About the Opportunity
Our client is a fast-growing pharmaceutical company that is seeking a Senior/Principal Data Management to join their team. This is a great opportunity to join a team that has always embraced new technologies and partnerships to accelerate product development and generate the clinical evidence for our clients require to demonstrate real-world value.
The annual base salary range is $90,000 to $140,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
- Review protocol and attend protocol review meetings or provide feedback, as needed
- Provide feedback, as requested, during development of eCRF specifications according to the protocol
- Assist in the design and review of study databases
- Author or review eCRF completion guidelines
- Develop or lead the review of a Data Management Plan (DMP), when applicable, that outlines database design and testing, data review and query handling, coding, SAE reconciliation, external data reconciliations, reports, database lock and archiving, etc.
- Develop or lead the review of edit check specifications, as well as perform/coordinate UAT
- Provide study metrics and status reports to internal and/or client teams
- Provide updates to team questions on program tasks and scope
- Perform or lead data cleaning activities
- Perform or lead SAE reconciliation activities
- Perform or lead external data reconciliation activities
- Perform or lead database lock and freeze activities
- Assist or generate study timelines
- Ensure approved study documents are maintained and properly stored in trial master file
- Minimum of a BA/BS (life science or mathematics related preferred)
- Minimum 4-7 years of experience of industry experience with at least 3-4 years of data management experience
- Proficient knowledge of Medidata RAVE, Oracle InForm and/or IBM Clinical Development