Associate Director, Data Management

Role Summary

The Associate Director, Clinical Data Management will drive the entire life cycle of key Zenas Data suppliers, from identification, selection, and on-boarding to performance management. This is an important cross-functional leadership position supporting within the R&D organization.

Responsibilities

• Implement data management vision for clinical data management on studies assigned by overseeing all clinical data management activities
• Manage the CRO/vendor for clinical data management activities on studies assigned including leading, overseeing, and approving CRO data management documentation to assure processes meet the protocol requirements ensuring data integrity and regulatory compliance
• Develop strong relationships to optimize collaborative cross-functional engagement internally and with vendors to align with company priorities, goals, and objectives
• Build and maintaining CRF standards to achieve cost efficiencies with external vendors and time efficiencies with Zenas colleagues
• Lead the cross-functional team in user acceptance testing of the clinical database to align with protocol and analysis needs for the collection and cleaning of data
• Assist the Head of Data Management by providing data management expertise in the preparation of project specific request for proposals, reviewing vendor specifications/budgets, and discussing/recommending vendor selection
• Write protocol specific oversight data review plans on studies assigned, facilitate the cross-functional oversight data review preparation and meetings including following all data issues to resolution
• Effectively manage functional area on assigned studies (resources, activities, processes, and documentation)
• Proactively identify potential data issues/risks plus recommend and implement solutions on assigned studies
• Collaborating with internal colleagues providing clinical data management expertise, leadership, and support to other functional leads to meet and maintain cross-functional excellence to meet company objectives
• Manage aspects of clinical data management activities, including vendor performance, internal metrics, quality assurance checks, and communication of study status within and outside the study team on assigned studies
• Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents by regularly auditing the Data Management section of the TMF to ensure complete and current CRO filing to meet regulatory requirements on assigned studies

Qualifications

• Bachelor‚Äôs degree required within a scientific discipline, math, computer science or related field with working knowledge of clinical data management processes and procedures
• Minimum 8 years of data management experience within biotech/biopharma preferably in fast paced biotech
• Experience with a CRO organization is a plus
• Demonstrated experience directly managing/overseeing clinical data management activities with external vendors/CROs including development/monitoring of clinical data metrics
• Extensive knowledge and experience in development/reviewing/execution of clinical data management study plans such as electronic case report specifications, edit checks, data management plans, data transfer specifications, coding plans, and electronic trial master plans (eTMF)
• Experience performing/leading teams to perform user acceptance testing
• Extensive data cleaning/data dredging experience
• Solid understanding of FDA/EU regulations and guidelines including GCP, ICH, CDASH, and CDISC as applicable to clinical data management
• Comprehensive understanding of database and dictionary structures (e.g., MedDRA, WHO DRUG)
• Exceptional interpersonal skills and problem-solving capabilities
• Excellent oral and written communication skills
• Flexible, collaborative, and results driven

Skills

• Clinical data management expertise
• Vendor management and performance oversight
• Regulatory knowledge (FDA/EU, GCP, ICH, CDASH, CDISC)
• Data quality assurance and issue resolution
• Cross-functional collaboration and stakeholder engagement

Education

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

Additional Requirements

• LI-Hybrid