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Manager / Senior Manager, Clinical Data Management
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- We are a clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.
- Our strategy is to become a leader in the treatment of rare diseases by leveraging our technology platform and applying the team's know how and expertise to the development of CTI-1601 and other future pipeline programs.
- Ability to development/oversee Data Management specific documentation including but not limited to the eCRF specifications, eCRF completion guidelines, edit check specifications, validation documents, DMP and DRP (Data Review Plan)
- At least 5-7 years of experience as a Senior or Lead Clinical Data Manager leading clinical data management activities for multiple studies or a clinical program(s) including oversight of multiple CROs and vendors
- Strong familiarity Medidata RAVE, Veeva EDC or Medrio
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