Senior Data Manager — Lead Data for Breakthrough Autoimmune Therapy

Vor Bio, Inc.; Boston (MA); On-site; USD 170,000 - 190,000; Full time

Benefits offered by this job

Comprehensive health coverage

Flexible paid time off

Generous parental leave

401(k) plan

Job summary

Vor Bio, Inc. is seeking a Senior Data Manager to oversee data management from study start-up through database lock, ensuring data integrity and regulatory compliance. You will lead DM activities, mentor staff, and coordinate with CROs and internal teams.

The role emphasizes quality, timelines, and proactive process improvements, with heavy focus on DM documentation, SDTM standards, and inspection readiness. A strong background in Medidata Rave is required.

Qualifications

• Bachelor's degree in computer sciences, health-related sciences, or relevant field and 7+ years of Data Management experience.
• Proven hands-on experience with data management tasks and DM vendor oversight to meet aggressive timelines.
• Extensive hands-on experience with clinical data management practices within industry sponsored clinical trials.
• In-depth knowledge of eCRF tools and trends in data collection.
• Proficient experience using commercial C-DMS/EDC systems, e.g. Medidata Rave.

Responsibilities

• Serve as data lead for one or more clinical trials, handling data management activities, access levels and permissions.
• Drive quality and efficiency to meet timelines in collaboration with cross-functional study teams.
• Oversee data management activities by CROs and 3rd party vendors throughout the life cycle.
• Be the first point of contact for DM partners to meet milestones with high quality.
• Ensure alignment with DM expectations for the assigned compound/indication.
• Review and provide input for DM documentation: CRF design, DMP, data transfer specs.
• Oversee edit check specifications to support data collection and analysis.
• Ensure the database adheres to CDISC/SDTM standards and suggest data collection improvements.
• Participate in clinical development planning and trial design discussions.
• Set and monitor data management milestones, ensuring inspection readiness.
• Mentor and motivate team members to achieve clinical goals.
• Follow SOPs and update guidelines as needed; develop DM documentation.
• Lead QA/QC and UAT of the clinical database prior to production.

Skills

Data management

Project management

Communication

Interpersonal skills

Prioritization

Team collaboration

Clinical data management

EDC systems

Education

Bachelor's degree in Computer Science or health-related sciences

Tools

Medidata Rave

R/R Shiny

Job description

Vor Bio, Inc. is seeking a Senior Data Manager to oversee data management from study start-up through database lock, ensuring data integrity and regulatory compliance. You will lead DM activities, mentor staff, and coordinate with CROs and internal teams.

The role emphasizes quality, timelines, and proactive process improvements, with heavy focus on DM documentation, SDTM standards, and inspection readiness. A strong background in Medidata Rave is required.