Principal Clinical Data Manager - Remote in San Diego

Travere Therapeutics; Wichita (KS); Hybrid; USD 116,000 - 151,000; Full time

Job summary

Travere Therapeutics is seeking a Principal Data Manager to oversee the start-up and execution of clinical trials, ensuring data quality, integrity, and regulatory compliance. The role leads data management deliverables, manages CROs and internal teams, and coordinates cross-functional study activities to deliver high-quality data.

The candidate should have strong knowledge of CDASH/SDTM, ICH/GCP compliance, and experience with Medidata RAVE.

Qualifications

• Demonstrated knowledge of drug development and Clinical Data Management processes.
• Experience designing trials using CDASH/SDTM standard terminology.
• Understanding of ICH Guidelines and GCP Requirements.
• Excellent communication and interpersonal skills.
• Well-versed in various EDC Systems; Medidata RAVE preferred.
• Experience managing outsourced studies and CRO data management teams.
• Experience leading data integrations using EDC, IRT, ePRO and external labs.
• Ability to leverage AI models to increase productivity.
• Ability to develop and maintain timelines.
• Dictionary coding (MedDRA/WHODrug) understanding.

Responsibilities

• Act as the single point of accountability for data management deliverables at an assigned level within a given clinical development program.
• Lead CDM to manage CROs and third-party vendors to ensure successful trial execution.
• Lead CDM to manage data management deliverables when sourced internally.
• Manage system integrations across data platforms.
• Ensure CRO and third-party data review outputs are filed in the Trial Master Plan as appropriate.
• Perform ongoing data review to identify discrepancies and resolutions.
• Review data for protocol deviation identification, dictionary coding, and UAT of database.
• Review documents produced by vendors and other departments.
• Create data management process documents (DM Plans, data review specs, data transfer agreements, workflows, timelines).
• Work cross-functionally with other departments and attend project team meetings as lead CDM.
• Strategize for database locks and multiple deliverables across studies within a program.
• Provide input on SOPs and study protocols from a data management perspective.
• Use AI models to increase productivity.
• Provide guidance to data management personnel on projects.
• Set-up, maintain and archive data management documentation (DM Plan, CRF Completion Guidelines).
• Independently monitor activities and status to meet timelines.
• Adhere to budgets and timelines.
• Ensure inspection readiness and compliance.
• Additional duties as needed.

Job description

Travere Therapeutics is seeking a Principal Data Manager to oversee the start-up and execution of clinical trials, ensuring data quality, integrity, and regulatory compliance. The role leads data management deliverables, manages CROs and internal teams, and coordinates cross-functional study activities to deliver high-quality data.

The candidate should have strong knowledge of CDASH/SDTM, ICH/GCP compliance, and experience with Medidata RAVE.