Senior Data Manager & CDM Lead — Remote

Travere Therapeutics

Columbia (SC)

Hybrid

USD 116,000 - 151,000

Full time

9 days ago

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Job summary

Travere Therapeutics is seeking a Principal Data Manager to oversee start-up and execution of clinical trials with CROs or in-house, ensuring data quality and regulatory compliance. The role requires leadership of data management deliverables, vendor oversight, and cross-functional collaboration across multiple studies within a program.

The position emphasizes standard data management practices, SDTM/CDASH, and leveraging AI to increase productivity while maintaining timelines and inspection

Qualifications

  • Lead data management for clinical programs with CROs.
  • Ensure data quality, integrity, and regulatory compliance.
  • Develop DM plans and specs.
  • Provide guidance on CDISC standards (SDTM/CDASH).

Responsibilities

  • Act as the single point of accountability for data management deliverables at an assigned level within a program.
  • Lead CDM to manage CROs and third‑party vendors for DM execution.
  • Lead CDM to manage data deliverables if sourced internally.
  • Manage system integrations across data platforms.
  • Review CRO and vendor outputs and file in the Trial Master Plan as appropriate.
  • Perform ongoing data review to identify discrepancies and resolutions.
  • Review documents from vendors and other departments.
  • Create data management process documents (DM plans, data transfer agreements).
  • Attend clinical trial project team meetings as lead CDM.

Skills

CDM lead
CRO oversight
Data management
EDC systems
Medidata RAVE
SDTM/CDASH
AI in data mgmt
team guidance

Tools

Medidata RAVE
EDC systems
CDMS

Job description

Travere Therapeutics is seeking a Principal Data Manager to oversee start-up and execution of clinical trials with CROs or in-house, ensuring data quality and regulatory compliance. The role requires leadership of data management deliverables, vendor oversight, and cross-functional collaboration across multiple studies within a program.

The position emphasizes standard data management practices, SDTM/CDASH, and leveraging AI to increase productivity while maintaining timelines and inspection

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