Remote Associate Director, Data Management

Travere Therapeutics

San Diego (CA)

On-site

USD 150,000 - 195,000

Full time

4 days ago
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Benefits offered by this job

Health benefits
Stock-based incentive
Generous PTO

Job summary

Travere Therapeutics is seeking an Associate Director, Data Management to lead start-up and execution of multiple trials with CROs or in-house teams. You will ensure data quality, integrity and regulatory compliance across programs, guiding timelines, audits and vendor oversight.

You will work with cross-functional teams, design and review data management plans, and drive process improvements to optimize data collection and database locks.

Qualifications

  • Bachelor’s degree in life science, pharmacy or related field.
  • 8+ years of direct Data Management experience.
  • Experience in vendor management and CROs.
  • Strong communication and interpersonal skills.
  • Knowledge of ICH/GCP guidelines.
  • Experience with Medidata RAVE and EDC systems.
  • Capable of managing multiple projects under tight timelines.
  • Understanding of CDASH and SDTM terminology.
  • Knowledge of MedDRA and WHODrug dictionary coding.
  • Willingness to travel ~10%.

Responsibilities

  • Leadership and accountability for DM deliverables in development programs.
  • Develop and maintain DM timelines for programs.
  • Lead DM in audits and regulatory inspections.
  • Act as DM SME at Study Management Team meetings.
  • Identify gaps in DM processes and drive improvements.
  • Oversee CROs and vendors in DM for trials.
  • Review data for discrepancies and trends; resolve issues.
  • Review protocol deviations, coding, and UAT of databases.
  • Review vendor and department documents.
  • Lead CDM in cross-functional project meetings.

Skills

Data management
Leadership
Vendor management
CDASH/SDTM
GCP/ICH
EDC systems
Project management
Communication

Education

Life science degree

Tools

Medidata RAVE
EDC systems

Job description

Travere Therapeutics is seeking an Associate Director, Data Management to lead start-up and execution of multiple trials with CROs or in-house teams. You will ensure data quality, integrity and regulatory compliance across programs, guiding timelines, audits and vendor oversight.

You will work with cross-functional teams, design and review data management plans, and drive process improvements to optimize data collection and database locks.

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