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Salary: USD 170,000 - 190,000 / annual
Vor Bio is a clinical-stage biotechnology company developing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor for autoimmune diseases. The company is advancing this therapy through Phase 3 trials in myasthenia gravis with expansion into multiple indications including lupus, IgA nephropathy, and Sjögren's syndrome.
The Senior Data Manager will serve as the data lead for one or more clinical trials, assuming full responsibility for all data management activities from study start-up through database lock and archiving. This role ensures completeness, accuracy, and consistency of clinical data while meeting regulatory standards for quality analysis and reporting.
Key responsibilities include:
- Leading all data management activities for assigned clinical trials, including access levels and permissions
- Driving quality and efficiency to meet timelines and milestones in close collaboration with cross-functional study teams
- Overseeing data management activities performed internally and by CROs and third-party vendors (IRT, Safety, Lab, etc.) throughout the study lifecycle
- Serving as the primary point of contact for data management partners to ensure milestones and deliverables are met with high quality
- Ensuring internal and external partners align with data management expectations for assigned compounds and indications
- Reviewing and providing input on all data management documentation including CRF design, Data Management Plans, and Data Transfer Specifications
- Overseeing edit check specifications to support data collection and analysis per protocol
- Ensuring clinical databases adhere to Clinical Data Acquisition Standards Harmonization guidelines for optimal SDTM dataset programming
- Identifying gaps in data collection and challenging unnecessary data collection
- Participating in clinical development planning and strategy
- Acting as a leader in the department through mentoring and consistent study delivery
- Contributing to continuous improvement initiatives
Requirements:
- Bachelor's degree in life sciences, clinical research, or related field
- Minimum 5+ years of clinical data management experience in pharmaceutical or biotech settings
- Experience with clinical trial data management from protocol through database lock
- Strong knowledge of electronic data capture (EDC) clinical data management systems
- Strong computer skills including Microsoft Office Suite and Medidata Rave
- Ability to understand and adapt to various IT systems
- Excellent organizational and communication skills
- Ability to work independently and manage multiple studies simultaneously
- Knowledge of regulatory requirements and GCP guidelines
Preferred qualifications:
- Working knowledge of R/R Shiny/Posit Connect or similar tools for data quality review, reconciliation, and dashboards
