Associate Director, Clinical Data Management

The role

The Associate Director, Clinical Data Management will provide technical expertise and vendor oversight for clinical programs. This role involves developing and executing Remix standards and processes for outsourced solutions.

What you will do

• Manage and provide operational oversight of functional deliverables from data management CROs and specialized vendors
• Establish and monitor CRO performance metrics, KPIs, and quality metrics
• Lead routine governance and alignment meetings to track study progress and resolve data issues
• Participate in CRO selection, RFP evaluations, and bid defense meetings
• Review and manage the DM vendor budget, including SoW and Change Orders
• Review and approve core vendor deliverables including DMPs, eCRF designs, Edit Check Specifications, UAT setups, and Data Transfer Specifications
• Lead data management activities from protocol review and study start-up through database cleaning, lock, and archival
• Conduct ongoing data reviews to identify data anomalies, trends, and systemic risks
• Ensure data operations adhere to ICH-GCP guidelines, corporate SOPs, and regulatory expectations
• Serve as the Data Management Subject Matter Expert during internal audits and Health Authority inspections

Required qualifications

• BS/BA in a scientific, informatics, or healthcare discipline
• Minimum of 8+ years of experience in clinical drug development focused on Clinical Data Management within a pharmaceutical, biotech, or CRO environment
• Deep expertise in industry-standard Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Veeva Vault CDMS)
• Advanced knowledge of global regulatory frameworks, including ICH-GCP, FDA guidelines, EMA requirements, and CDISC standards
• Proven track record of managing full-service data management CROs and external vendors for complex or multi-center clinical trials
• Experience supporting clinical programs from IND through NDA submission and regulatory approval, including registrational trials and Inspection Readiness

Nice to have

• Master’s or Ph.D.
• Deep oncology or rare disease trial experience

About the company

Remix Therapeutics is a clinical-stage biopharmaceutical company that has pioneered a new class of small molecule medicines targeting the RNA splicing machinery. Their lead program REM-422 is focused on developing a therapy for Adenoid Cystic Carcinoma (ACC).