- 3+ years of experience managing clinical studies in a data management role (Device, Pharma, or Biotech).
- Strong proficiency in EDC systems (Rave, IBM, Oracle, etc)
- Exceptional organizational skills, attention to detail and follow through.
- Ability to effectively and efficiently handle multiple tasks simultaneously with precision and adapt to changes in responsibilities and workloads.
- Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA and GDPR guidelines, and other confidential information
- Work with database programmer and study team to design EDC database. This includes eCRF creation, edit check specifications, and database specifications.
- Perform and document EDC database UAT.
- Author essential data management documents for clinical studies (CCGs, Data Management Plan, Data Transfer Specs, etc)
- Review and provide input into Protocol, SAPs, etc
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