Associate Director, Data Management

Travere Therapeutics • San Diego, CA

1d • $150,000 - $195,000 • Remote

About The Position

The Associate Director, Data Management oversees the start-up and execution of several clinical trials, either with a CRO or in-house, to ensure data quality and integrity. This role provides data management leadership across clinical development programs and performs complex work to ensure data are complete, accurate, high quality, and compliant with regulations in support of publications and regulatory submissions. The position also provides guidance to clinical data management personnel and works cross-functionally with internal teams, CROs, and third-party vendors.

The role is listed as San Diego, USA—Remote, but all positions require the ability to perform face-to-face work with colleagues and/or onsite in San Diego; no role is expected to be 100% remote. Travel may be required as necessary, approximately 10%.

Requirements

• Bachelor’s degree in life science, pharmacy, or a related field; an equivalent combination of education and applicable job experience may be considered.
• At least 8 years of direct Data Management experience.
• Prior clinical trial vendor management and integration experience.
• Excellent communication and interpersonal skills.
• Ability to solve complex problems, take corrective action, and identify and implement improvements.
• Knowledge of Clinical Data Management processes and ability to guide peers.
• Initiative, sound judgment, flexibility, effective time management, and organizational skills; ability to manage multiple projects under tight timelines or stress.
• Project management skills, including planning, organizing, and managing activities toward measurable study goals and objectives.
• Ability to interact professionally with internal and external personnel at all levels; dependability and teamwork.
• Clear understanding of the drug development process.
• Understanding of ICH Guidelines and GCP requirements.
• Experience or understanding of dictionary coding, including MedDRA and WHODrug, and vendor reconciliation.
• Ability to develop and maintain timelines.
• Knowledge of different EDC systems.
• Experience leading data integrations involving EDC, IRT, ePRO, and external laboratory processing.
• Self-motivation and ability to manage responsibilities independently.
• Accountability and ownership of decisions and actions, including in ambiguous circumstances.
• Ability to travel as necessary, approximately 10%.
• Ability to perform face-to-face work with colleagues and/or work onsite in San Diego.

Nice To Haves

• Experience managing outsourced studies and working for a CRO.
• Proficiency in Medidata RAVE.
• Experience using Artificial Intelligence models to create efficient data collection methodologies or enhance data quality.

Responsibilities

• Provide leadership and accountability for data management deliverables within a development program.
• Develop, maintain, and execute data management timelines for a development program.
• Lead data management activities in program-related audits and regulatory inspections.
• Serve as a data management subject matter expert at Study Management Team meetings.
• Identify gaps in data management processes and champion process improvements and efficiencies.
• Lead clinical data management and oversee CROs and third-party vendors to support successful trial implementation, execution, and completion.
• Review clinical data to identify discrepancies, trends, and resolutions as part of CRO oversight.
• Review data for protocol deviations and oversee coding and user acceptance testing of databases.
• Review documents produced by vendors and other departments.
• Work cross-functionally, assess departmental needs, and attend clinical trial project team meetings as Lead CDM.
• Plan for database locks and multiple deliverables across programs.
• Provide data management input on standard operating procedures and study protocols.
• Guide clinical data management personnel on assigned projects.
• Set up, maintain, and archive data management project documentation, including Data Management Plans and CRF Completion Guidelines.
• Monitor personal activities and project status to deliver work successfully according to timelines.
• Maintain project inspection readiness and compliance.
• Design clinical trials using CDASH and SDTM standard terminology.
• Manage system integrations across data platforms.
• Perform additional duties as assigned.

Benefits

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance and disability coverage.
• Retirement plans with employer match.
• Generous paid time off.
• Cash compensation comprising base pay and a short-term incentive.
• Long-term incentive compensation in company stock.

What This Job Offers

• Job Type: Full-time
• Career Level: Director