Senior Data Manager & CDM Lead (Remote)

Travere Therapeutics; Manchester (NH); On-site; USD 116,000 - 151,000; Full time

Benefits offered by this job

Premium health

Life insurance

Retirement plans with employer match

Generous PTO

Job summary

Travere Therapeutics, a biopharma focused on rare diseases, seeks a Principal Data Manager to oversee start-up and execution of clinical trials with CROs or in-house teams. You will ensure data quality, integrity, and regulatory compliance for publications and submissions.

You will lead data management deliverables, manage vendors, drive data standardization (CDASH/SDTM), and implement DM processes while collaborating across functions. This role requires onsite work in San Diego with ~10% travel.

Qualifications

• Demonstrated knowledge of drug development and Clinical Data Management processes.
• Expertise designing trials using CDASH and SDTM standard terminology.
• Understanding of ICH Guidelines and GCP Requirements.

Responsibilities

• Act as the single point of accountability for data management deliverables within a program.
• Lead CDM to manage CROs and vendors for DM
• Oversee data management deliverables whether sourced internally
• Manage system integrations across data platforms
• Review CRO and third-party data outputs per plan and TM Plan
• Perform data review to identify discrepancies and resolutions
• Review protocol deviations, dictionary coding, and UAT of databases
• Create DM documentation (Data Management Plan, data transfer agreements)
• Collaborate cross-functionally with other departments on trial needs
• Plan database locks and multiple deliverables across studies
• Input on SOPs and study protocols from a DM perspective
• Use AI models to increase productivity
• Guide DM personnel on projects
• Maintain DM project documentation and timelines
• Ensure adherence to budgets, timelines and inspection readiness
• Additional duties as needed

Skills

Data management leadership

CDM oversight

Communication skills

Tools

Medidata RAVE

EDC systems

Job description

Travere Therapeutics, a biopharma focused on rare diseases, seeks a Principal Data Manager to oversee start-up and execution of clinical trials with CROs or in-house teams. You will ensure data quality, integrity, and regulatory compliance for publications and submissions.

You will lead data management deliverables, manage vendors, drive data standardization (CDASH/SDTM), and implement DM processes while collaborating across functions. This role requires onsite work in San Diego with ~10% travel.