Lead Clinical Data Manager – Trials (Remote)

Travere Therapeutics; Minneapolis (MN); On-site; USD 116,000 - 151,000; Full time

Benefits offered by this job

Health insurance

Job summary

Travere Therapeutics is seeking a Principal Data Manager to lead and manage data from clinical trials, ensuring high quality, regulatory-compliant data when partnering with CROs or internal teams. You will oversee data management deliverables, drive system integrations, and guide teams to maintain data integrity throughout studies.

The role requires expertise in CDASH/SDTM, ICH/GCP, and experience with Medidata RAVE, EDC/IRT/ePRO, and vendor management.

Qualifications

• Extensive experience in clinical trial data management and DM deliverables.
• Proficiency with CDASH and SDTM terminology in trial datasets.
• Strong knowledge of ICH guidelines and GCP requirements.
• Excellent written and verbal communication, with cross-functional collaboration skills.
• Experience leading CRO data management teams and outsourced studies.
• Ability to design and optimize data management processes and SOPs.
• Willingness to travel approximately 10%.

Responsibilities

• Act as the single point of accountability for data management deliverables within a program.
• Lead CDM to oversee CROs and third-party vendors for DM execution.
• Oversee data management deliverables when data is sourced internally.
• Manage system integrations across data platforms.
• Ensure CRO/vendor data reviews are filed in the Trial Master Plan.
• Perform ongoing data review to identify discrepancies and trends.
• Review data for protocol deviations and dictionary coding; perform UAT.
• Review vendor and departmental documents for accuracy.
• Create data management plans, data review specs, data transfer agreements and workflows.
• Collaborate cross-functionally and attend clinical study team meetings as lead CDM.
• Strategize and plan database locks and deliverables across studies to ensure consistency.
• Provide input on SOPs and study protocols from a DM perspective.
• Utilize AI models to improve data efficiency and productivity.
• Guide DM staff on projects and maintain project documentation.
• Monitor activity status, budgets, and timelines; ensure inspection readiness.
• Additional duties as needed.

Skills

Lead CDM

Data management

CDASH SDTM

ICH/GCP

Medidata RAVE

CRO management

Data integrations

AI models

Project management

Dictionary coding

EDC IRT ePRO

Communication

Travel readiness

Job description

Travere Therapeutics is seeking a Principal Data Manager to lead and manage data from clinical trials, ensuring high quality, regulatory-compliant data when partnering with CROs or internal teams. You will oversee data management deliverables, drive system integrations, and guide teams to maintain data integrity throughout studies.

The role requires expertise in CDASH/SDTM, ICH/GCP, and experience with Medidata RAVE, EDC/IRT/ePRO, and vendor management.