Principal Clinical Data Manager – Remote Leadership

Travere Therapeutics; Des Moines (IA); On-site; USD 116,000 - 151,000; Full time

Job summary

Travere Therapeutics in San Diego is seeking a Principal Data Manager to oversee the 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, manage CROs, and drive data integrations across platforms, focusing on SDTM/CDASH, ICH/GCP, and audit readiness. This role emphasizes collaboration, strategic planning, and adherence to timelines.

Qualifications

• Knowledge of drug development and clinical data management processes.
• Experience with CDASH and SDTM standard terminology.
• Understanding of ICH Guidelines and GCP Requirements.
• Excellent communication and interpersonal skills.
• Experience managing outsourced studies and CRO data management teams.
• Experience in data integrations using EDC, IRT, ePRO and external lab processing and vendor reconciliation.
• Ability to leverage AI models for data efficiencies.
• Understanding of dictionary coding (MedDRA/WHODrug).
• Willingness to travel ~10%.
• Face-to-face work onsite in San Diego; not 100% remote.

Responsibilities

• Act as the single point of accountability for data management deliverables within a clinical development program.
• Lead CDM to manage CROs and vendors to ensure trial execution and data integrity.
• Manage all data management deliverables when sourced internally.
• Oversee system integrations across data platforms.
• Review CRO/vendor data outputs and file in the Trial Master Plan.
• Perform ongoing data reviews to identify discrepancies and resolutions.
• Review protocol deviations, dictionary coding, and perform UAT of databases.
• Create DM plans, data review specifications, and data transfer agreements.
• Collaborate cross-functionally and attend project team meetings as lead CDM.
• Plan database locks and deliverables across studies to ensure consistency.
• Contribute to SOPs and study protocols from a data management perspective.
• Provide guidance to DM personnel and ensure timely delivery.
• Set up and archive data management documentation.
• Monitor activities and ensure compliance with budgets and timelines.
• Ensure inspection readiness and regulatory compliance.

Skills

Data Management

CDM Lead

CRO Management

EDC Systems

Medidata RAVE

Data Integrations

GCP/ICH Guidelines

AI in Data

Project Management

Timeline Development

Communication

Tools

Medidata RAVE

EDC Platforms

Job description

Travere Therapeutics in San Diego is seeking a Principal Data Manager to oversee the 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, manage CROs, and drive data integrations across platforms, focusing on SDTM/CDASH, ICH/GCP, and audit readiness. This role emphasizes collaboration, strategic planning, and adherence to timelines.