Senior Clinical Data Manager – Remote Lead

Travere Therapeutics; Kansas City (MO); On-site; USD 116,000 - 151,000; Full time

Job summary

Travere Therapeutics in San Diego is seeking a Principal Data Manager to lead data management for clinical programs. You will oversee startup and execution of trials, act as lead CDM with CROs or in-house teams, ensure data quality, integrity and regulatory compliance for publications and submissions.

Responsibilities include managing DM deliverables, reviewing vendor data outputs, creating data management plans, and guiding junior staff.

Qualifications

• Demonstrated knowledge of drug development and Clinical Data Management processes and capable of guiding peers.
• Experience designing trials with CDASH/SDTM terminology.
• Understanding of ICH and GCP requirements.

Responsibilities

• Act as the single point of accountability for data management deliverables within a program.
• Lead CDM to oversee CROs/ Vendors for data management in trials.
• Manage data platform integrations and data review workflows.
• Develop DM plans, data review specs, and transfer agreements.
• Collaborate cross-functionally and lead trial team meetings as lead CDM.
• Plan database locks and multiple study deliverables across programs.

Skills

Clinical Data Management

CDASH

SDTM

ICH Guidelines

GCP compliance

Project management

Vendor management

Leadership

Communication

Tools

Medidata RAVE

EDC systems

Data integration

Job description

Travere Therapeutics in San Diego is seeking a Principal Data Manager to lead data management for clinical programs. You will oversee startup and execution of trials, act as lead CDM with CROs or in-house teams, ensure data quality, integrity and regulatory compliance for publications and submissions.

Responsibilities include managing DM deliverables, reviewing vendor data outputs, creating data management plans, and guiding junior staff.