Associate Director, Data Management

📋 Description

• Lead data management across studies from start-up to close-out.
• Represent data management in cross-functional meetings.
• Lead regular cross-functional data review meetings.
• Oversee data cleaning, queries, resolutions, and coding review.
• Oversee external lab data reconciliation and data transfer agreements.
• Lead database lock activities and archiving of study data.
• Supervise and mentor data managers to ensure quality.
• Lead eCRF development and cross-functional reviews of specs.
• Oversee database building, edit-check review, and user acceptance testing.
• Monitor data collection by CROs and track study metrics.
• Review DM plans, CRF guidelines, data transfer specs; file in eTMF for regulatory inspection.
• Use data visualization tools for data review with cross-functional teams.
• Review clinical study protocols and statistical analysis plans.
• Participate in other DM/Biometrics activities as needed.
• Support SOPs, working instructions, and templates for Data Management.

🎯 Requirements

• Excellent interpersonal, conflict management, and negotiation skills.
• B.S./B.A. in scientific discipline; 7 years DM exp; 4 years in leading or vendor oversight.
• Experience with MedDRA and WHODrug dictionaries.
• Proficient with EDC systems (Veeva EDC, Medidata-RAVE) and CRF/eCRF design.
• Experience in outsourced data management models.
• Excellent verbal and written communication, organization, and time management.