Associate Director, Clinical Data Management

Role Summary

Associate Director, Clinical Data Management. Reporting directly to the Vice President of Clinical Development, this role shapes data management strategies, oversight, outsourcing, and risk-based approaches to ensure compliant and efficient clinical data practices.

Responsibilities

• Leads and manages all clinical data management (DM) activities including database build, cleaning, reconciliation, and locking 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 digital/AI solutions to improve study efficiency and quality of data collection.
• Collaborates 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

• Bachelor‚Äôs degree in life sciences, health informatics, or a related field (Master‚Äôs or higher degree preferred).
• 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.
• Competencies: Multi-Tasking, Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Adaptability, Strong Written and Verbal Communications.
• Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid position based in Xeris‚Äô Chicago office. A minimum of three days per week on-site is required. On-site requirements may change at management‚Äôs discretion.

Skills

• Leadership and people development
• Vendor management and outsourcing oversight
• Regulatory and quality compliance (GCP, FDA/EMA/ICH)
• Data management strategy and process improvement

Education

• As listed in Qualifications above.