Lead Clinical Data Manager – Remote/SD Trials

Travere Therapeutics; Detroit (MI); Hybrid; USD 116,000 - 151,000; Full time

Benefits offered by this job

Premium health

Financial benefits

Well-being programs

Retirement plans

Paid time off

Job summary

Travere Therapeutics in San Diego is seeking a Principal Data Manager to oversee start-up and execution of clinical trials with CROs or in-house teams, ensuring data quality and regulatory compliance. You will lead data management deliverables and drive data integrity across studies.

You will manage vendor relationships, develop data management plans, and contribute to SOPs while leveraging AI to enhance efficiency and maintain inspection readiness in a fast-paced environment.

Qualifications

• Experience in clinical data management with CDISC standards and SDTM
• Knowledge of ICH/GCP guidelines and regulatory expectations
• Ability to lead data management deliverables and CRO/vendor oversight

Responsibilities

• Act as the single point of accountability for data management deliverables
• Lead CDM to manage CROs and vendors for trial execution
• Oversee data management deliverables when sourced internally
• Manage system integrations across data platforms
• Review CRO data outputs and file in the Trial Master Plan
• Perform ongoing data review to identify discrepancies and resolutions
• Review protocol deviations, dictionary coding, and UAT of databases
• Create data management plans, data review specs, and data transfer agreements
• Collaborate cross-functionally in clinical trial teams as lead CDM
• Plan database locks and multi-study deliverables across programs
• Contribute to SOPs and study protocols from a data perspective
• Use AI models to increase productivity
• Provide guidance to CDM personnel on projects
• Maintain and archive data management documentation

Skills

Data management

Lead CDM

CRO management

Data integration

AI in data management

Communication skills

Medidata RAVE

Tools

Medidata RAVE

Job description

Travere Therapeutics in San Diego is seeking a Principal Data Manager to oversee start-up and execution of clinical trials with CROs or in-house teams, ensuring data quality and regulatory compliance. You will lead data management deliverables and drive data integrity across studies.

You will manage vendor relationships, develop data management plans, and contribute to SOPs while leveraging AI to enhance efficiency and maintain inspection readiness in a fast-paced environment.