Lead Clinical Data Manager — Remote & AI-Driven

Travere Therapeutics; San Diego (CA); Hybrid; USD 116,000 - 151,000; Full time

Benefits offered by this job

Premium health benefits

Financial and retirement plans

Generous paid time off

Job summary

Travere Therapeutics is seeking a Principal Data Manager in San Diego to oversee data management for clinical trials, ensuring quality and regulatory compliance. The role partners with CROs and in-house teams to deliver accurate data for publications and submissions.

Key responsibilities include leading the data management deliverables, overseeing CRO/vendor activities, and ensuring data integration across platforms, with a focus on SDTM/CDASH and ICH/GCP guidelines.

Qualifications

• Experience in data management for clinical trials and regulatory submissions.
• Ability to lead CRO data management teams and vendors.
• Familiarity with CDISC standards (SDTM/CDASH) and ICH/GCP guidelines.
• Proven ability to develop and maintain project timelines.

Responsibilities

• Act as the single point of accountability for data management deliverables in a program.
• Lead CDM to oversee CROs and vendors for trial data management.
• Manage data platform integrations and data review outputs.
• Develop data management plans, data transfer agreements, and workflows.
• Collaborate cross-functionally to align data needs with study objectives.
• Plan for databases locks and multiple deliverables across studies.
• Provide guidance on SOPs and study protocols from a data perspective.

Skills

Data management

CDM leadership

Regulatory compliance

AI data optimization

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Tools

Medidata Rave

EDC systems

SDTM/CDASH standards

Job description

Travere Therapeutics is seeking a Principal Data Manager in San Diego to oversee data management for clinical trials, ensuring quality and regulatory compliance. The role partners with CROs and in-house teams to deliver accurate data for publications and submissions.

Key responsibilities include leading the data management deliverables, overseeing CRO/vendor activities, and ensuring data integration across platforms, with a focus on SDTM/CDASH and ICH/GCP guidelines.