Associate Director, Data Management

Role Summary

The Associate Director, Data Management will be responsible for performing or overseeing vendors to perform Data Management operational end-to-end activities and participate as an active member in a cross-function study team to plan, lead, and execute tasks required for assigned clinical studies across all phases. The role requires broad, fundamental knowledge of the data management process with the ability to perform most tasks with minimal guidance.

Responsibilities

• Lead Data Management of a clinical study or a series of related studies with minimal guidance
• Manage and monitor the progress of data management activities with CROs, vendors, and stats/programming groups on assigned studies
• Review protocols for appropriate data capture, including electronic Case Report Form (eCRF) design
• Perform a thoroughly detailed review of eCRF data requirements
• Lead the development of data edit check specifications and data listings
• Coordinate Electronic Data Capture (EDC) system design and testing according to company standards
• Develop or lead the development of the Data Management and Data Transfer Plan for assigned clinical studies
• Attend study meetings and provide Data Management updates and metrics
• Review and provide feedback to the clinical team on other study documents, e.g. Clinical Monitoring plans, Statistical Analysis Plans, and vendor specifications
• Provide training on the EDC system and/or eCRF Completion Guidelines to internal and external study team members as needed
• Perform or ensure assigned CRO reconciliation of header data from external data sources against the clinical database
• Perform or ensure assigned CRO completed Serious Adverse Event reconciliation activities according to SOPs and guidelines
• Lead database upgrades/migrations, including performing User Acceptance Testing
• Maintain data management files / eTMF
• Perform and coordinate database interim snapshot, lock, and freeze activities
• Other duties as assigned

Qualifications

• B.A./B.S. degree or higher (life-science-related fields preferred); or equivalent experience.
• 9+ years of data management experience in the biotech/pharmaceutical industry or clinical data management service providers, including at least 3+ years in a lead study data manager role
• Experience in retina diseases and/or gene therapies is a plus
• Operational experience as Data Management Lead in all phases of clinical trials, including database development/deployment/validation/maintenance/closeout, data transfers/reconciliations, and training on data management systems
• Experience in vendor management and performance assessments
• In-depth knowledge and experience with CDISC data standards and models

Other Qualifications/Skills

• Proficient in using clinical data management systems (e.g., Medidata Rave) and data flow from external sources (IRT, safety, labs, reading centers, PROs, etc.)
• Knowledge of Good Clinical Data Management Practices (GCDMP) in global clinical trials
• Knowledge of ICH GCP and other regulatory guidelines
• Knowledge of the clinical development process
• Proficient with MS Office (Word, Excel, PowerPoint)
• Excellent interpersonal communication skills
• Collaborative attitude and ability to work in a fast-paced small company environment
• Strong organization and project/time management skills
• Ability to multitask in a high-volume environment with shifting priorities
• Conceptual, analytical, and strategic thinking
• Excellent attention to detail

Travel

5%

Physical Requirements and Working Conditions

• Physical Activity - Repetitive motions related to wrists, hands, and/or fingers; typing; speaking
• Physical Requirements - Sedentary work with potential lifting up to minimal weight as needed
• Working Conditions - Not substantially exposed to adverse environmental conditions