Associate Director, Clinical Data Management

Role Summary

Reporting directly to the Vice President of Clinical Development, this individual plays a key role in development of data management strategies including outsourcing, oversight and risk-based data management strategies, standards and processes. The Associate Director, Data Management will bring deep knowledge of industry best practices, regulatory requirements, and systems and processes that support efficient and compliant clinical data practices.

Responsibilities

• Leads and manages all clinical data management (DM) activities including database build, cleaning, reconciliation, and locking activities across multiple clinical trials to ensure timely, accurate, and complete data collection and analyses.
• Develops and implements data management strategies, processes, and standards in alignment with Good Clinical Practices (GCP) and applicable regulatory guidelines (e.g., FDA, EMA, ICH).
• Oversees the review of key data management documents and operational activities (e.g., data management plans [DMPs], case report forms [CRFs], CRF completion instructions, data validation specifications, and edit checks) outsourced to CROs ensuring adherence to cost, timeline, and data quality requirements.
• Participates in clinical vendor selection for external DM vendors including responsibility for review of DM sections of proposals, budgets, statements of work and change orders.
• Pilots and implements available digital/AI solutions to improve study efficiency and quality of data collection.
• Collaborates closely with Clinical Research Operations, Medical, Pharmacovigilance, and Biostatistics to ensure seamless data flow and data review leading to clean datasets for analysis.
• Ensures storage of all DM documents in the trial master file to support inspection.
• Mentors junior staff and contributes to departmental growth and development.

Qualifications

• Minimum of 8 years of clinical data management experience in the pharmaceutical, biotechnology, or CRO industry, including at least 3 years in a leadership or supervisory role.
• In-depth knowledge of CDM processes, regulatory standards (FDA, EMA, ICH-GCP), and clinical data standards (e.g., CDISC, SDTM).
• Hands-on experience with EDC systems (e.g., Medidata Rave, Veeva, Zelta), coding dictionaries (e.g., MedDRA, WHO Drug), and data visualization tools a plus.
• Proven ability to manage multiple projects and vendors simultaneously.
• Strong leadership, organizational, and communication skills.
• Experience supporting regulatory submissions is highly desirable.

Skills

• Multi-Tasking
• Teamwork & Collaboration
• Attention to Detail
• Self-Starter
• Analytical skills
• Problem Solving
• Organizational skills
• Adaptability
• Strong Written and Verbal Communications

Education

• Bachelor’s degree in life sciences, health informatics, or a related field (Master’s or higher degree preferred).

Additional Requirements

• Hybrid position based in Chicago office; minimum three days per week on-site; periodic overnight travel; may require periodic evening and weekend work as needed.