Associate Director, Data Management

Role Summary

Associate Director, Data Management at Zenas Biopharma. Responsible for driving the life cycle of key data suppliers, including identification, onboarding, performance management, and cross-functional leadership within R&D to ensure data quality, integrity, and regulatory compliance.

Responsibilities

• Implement data management vision for clinical data management on assigned studies by overseeing all activities
• Manage CRO/vendor for clinical data management, including leading, overseeing, and approving documentation to ensure protocol alignment and regulatory compliance
• Develop strong cross-functional relationships with internal teams and vendors to align with company priorities
• Establish and maintain CRF standards to optimize cost and time efficiencies with vendors and colleagues
• Lead cross-functional user acceptance testing of the clinical database to support data collection and cleaning needs
• Support project proposals, review vendor specifications/budgets, and participate in vendor selection discussions
• Prepare protocol-specific data review plans and facilitate cross-functional review meetings to resolve data issues
• Manage resources, activities, processes, and documentation within the functional area
• Identify potential data issues/risks and implement solutions for assigned studies
• Collaborate with internal colleagues to provide management expertise and support cross-functional leads to achieve company objectives
• Oversee aspects of data management activities, including vendor performance, metrics, QA checks, and study status communication
• Ensure archival and inspection readiness of TMF data management documents through regular audits

Qualifications

• Bachelor‚Äôs degree in a scientific discipline, math, computer science, or related field; working knowledge of clinical data management
• Minimum 8 years of data management experience in biotech/biopharma, preferably fast-paced
• Experience with a CRO is a plus
• Experience managing/overseeing clinical data management with external vendors/CROs and developing/monitoring data metrics
• Extensive knowledge of study plans and data management documentation (eCRF specs, edit checks, DMPs, data transfer specs, coding plans, eTMF)
• Experience leading user acceptance testing
• Extensive data cleaning experience
• Strong understanding of FDA/EU regulations and guidelines (GCP, ICH, CDASH, CDISC) as relates to data management
• Knowledge of database and dictionary structures (e.g., MedDRA, WHO DRUG)
• Excellent interpersonal, communication, and problem-solving skills
• Flexible, collaborative, and results-driven

Skills

• Clinical data management
• Vendor management
• Cross-functional collaboration
• Data quality and integrity
• Regulatory compliance
• Study documentation and TMF management
• User acceptance testing
• Data risk assessment and issue resolution

Education

• Bachelor‚Äôs degree in a scientific discipline or related field