Associate Director, Data Management

Travere • San Diego, CA

3d • Remote

About The Position

The Associate Director, Data Management oversees the start-up and execution of multiple clinical trials, either with a CRO or in-house, to ensure data quality and integrity. This role provides clinical development program leadership for data management and performs complex work to ensure data are complete, accurate, high quality, and regulatory compliant in support of publications and regulatory submissions. The position leads data management deliverables and CRO/vendor oversight, contributes data management expertise to study teams, and supports inspection readiness and compliance. The role is based remotely in the USA, with an essential function of performing face-to-face work with colleagues and/or onsite in San Diego; it is not 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 and increasingly difficult problems, take corrective action, and identify and implement improvements.
• Knowledge of Clinical Data Management processes and ability to provide guidance to peers.
• Initiative, sound judgment, flexibility, effective time management, and organizational skills; ability to manage multiple projects simultaneously under tight timelines or heavy stress.
• Project management skills, including planning, organizing, and managing activities to achieve study goals and measurable targets.
• Ability to interact professionally with personnel at all levels inside and outside the company; dependable and a team player.
• 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.
• Experience with different EDC systems.
• Ability to lead data integrations using EDC, IRT, ePRO, and external laboratory processing.
• Self-motivation and ability to independently manage responsibilities.
• Ability to travel as necessary, approximately 10%.
• Ability to perform face-to-face work with colleagues and/or onsite in San Diego.

Nice To Haves

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

Responsibilities

• Lead and be accountable 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.
• Lead and participate as a data management subject matter expert at Study Management Team meetings.
• Identify gaps in program data management processes and champion process changes and efficiencies.
• Serve as Lead CDM, managing and providing daily oversight of CROs and third-party vendors to support successful clinical trial implementation and execution through completion.
• Conduct ongoing clinical data review to identify discrepancies, trends, and resolutions as part of CRO oversight.
• Review data for protocol deviations; review coding and conduct user acceptance testing of databases.
• Review documents produced by vendors and other departments.
• Work cross-functionally to assess other departments’ needs and attend clinical trial project team meetings as Lead CDM.
• Strategize and plan database locks and multiple deliverables across programs.
• Provide data management input on standard operating procedures and study protocols.
• Provide guidance to clinical data management personnel on assigned projects.
• Set up, maintain, and archive data management project documentation, including Data Management Plans and CRF Completion Guidelines.
• Independently monitor activities and project status to deliver work according to timelines.
• Keep projects in a reasonable state of 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 the form of company stock.

What This Job Offers

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