Senior Data Manager

Summary

Join 4DMT, a clinical-stage biotherapeutics company, as a Senior Data Manager. You will lead data management for clinical studies, overseeing vendors and collaborating with cross-functional teams. Responsibilities include managing data management activities, reviewing protocols and data requirements, developing data specifications, coordinating EDC system design, and providing training. The ideal candidate possesses 8+ years of data management experience in biotech/pharma, in-depth knowledge of CDISC standards, and proficiency in clinical data management systems. A Bachelor's degree or higher is required, with a Master's degree considered a plus with reduced experience. 4DMT offers a competitive salary and a collaborative work environment.

Requirements

• Bachelor’s degree or higher (life-science-related fields preferred)
• 8+ years of data management experience in the biotech/pharmaceutical industry or clinical data management service providers. 6+ years and a Master’s degree. Of which at least three (3+) years in a lead study data manager role
• Hands-on operational experience as Data Management Lead in all phases of clinical trials, including development/deployment/validation/maintenance/closeout of a clinical database, coordination of data transfers/reconciliations, training on data management systems, etc
• Experience in vendor management and performance assessments
• In-depth knowledge and experience with CDISC data standards and models
• Proficient in using clinical data management systems (e.g., Medidata Rave) and the data flow, including those from external sources (IRT, safety, central/specialty labs, reading centers, PROs, etc.)
• Proficiency in data management process and knowledge of Good Clinical Data Management Practices (GCDMP) in global clinical trials
• Knowledge of ICH GCP and other applicable regulatory rules and guidelines
• Knowledge of the clinical development process
• Proficient with MS Office (Worl, Excel, PowerPoint, etc.)
• Excellent interpersonal communication skills (written and verbal)
• Innate collaborative attitude, with demonstrated ability to work effectively in a small company environment that moves at a tremendous pace
• Excellent organization and project/time management skills
• Ability to multitask in a high-volume environment with shifting priority and conflicting deadlines
• Proven conceptual, analytical and strategic thinking
• Excellent attention to details

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

Preferred Qualifications

Experience in retina diseases and/or gene therapies

Benefits

Base salary compensation range: $159,000 - $210,000