Senior Data Manager

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

J oin Us in Tackling Autoimmune Disease at Its Root

At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide.

When you join Vor, you’re not just working on a medicine. You’re part of a mission to redefine the future of autoimmune care.

Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases.

Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond.

Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome.

Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.

TheSeniorData Manageris responsible forall data management activities from study start-up through database lock and archiving and independently supporting the needs of the clinical study and programs of studies.TheSeniorData Manager will ensure completeness,accuracyand consistency and meet the standards of quality analysis and reporting to regulatory bodies.In addition, theSeniorData Manager has an active role in continuous improvement and acts as a leader in the department asdemonstratedby successful mentoring and consistent study delivery over time.

Responsibilities

• Serves as data lead for one or more clinical trials, assuming responsibility for all data management activities, including access levels and permissions.
• Proactively drive quality and efficiency to meet timelines and milestones for data management in close collaboration with cross functional study team(s)
• Conduct oversight of data management activities internally and performed by the CROs and other 3rd party vendors (IRT, Safety, Lab, etc.) to meet Vor obligations and business objectives throughout study (ies) life cyclei.e.from protocol synopsis through database release and submission.
• Serve as a first point of contact for DM partners to ensure established milestones and deliverables are met with the highest degree of quality
• Ensure the internal and external partners align and conform to data management expectations for the assigned compound and/or indication.
• Review and provide input for all DM documentation - CRF design and completion Guidelines, Data Management Plan, Data Transfer Specifications, etc.
• Oversee edit check specifications to support data collection and analysis required per protocol.
• Ensure the clinical database adheres to Clinical Data Acquisition Standards Harmonization guidelines allowing for optimal SDTM dataset programming. Suggest design for standard and non-standard data collection, identify any gaps in data collection, and challenge collection of unnecessary data.
• Participate in the creation of the clinical development plan, describing the clinical development strategy and possible innovative trial designs.
• Set quality expectations and timelines for data management deliverables and regularly follow up on data management milestones. Ensure inspection readiness at all times.
• Set expectations and communicate and a transparent, clear way and motivate team members to work towards achieving the clinical goals.
• Follow department and company standard operating procedures (SOPs), forms, templates and policies. Provide feedback and update these guidelines as needed.
• Develop, review, and maintain all study Data Management documentation.
• Take responsibility for and guide effective quality control (QC) review and user acceptance testing (UAT) of the clinical database prior to its release into production, including oversight of staff performing these tasks.
• Ensure data are properly reviewed in accordance with the Data Management Plan (DMP) and guidelines and that cleaning is effective and timely.
• Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager.
• Provide input into improving the efficiency of data management tasks.
• Lead and participate in interdepartmental or interdepartmental process and quality improvement initiatives.

Requirements

• Bachelor's Degree in computer sciences, health-related sciences, or relevant field and 7+ years of Data Management experience.
• Proven hands-on, direct, individual contributor experience with all data management tasks as well as DM vendor oversight to meet aggressive timelines of high-quality data deliverables.
• Extensive hands-on experience with clinical data management practices within industry sponsored clinical trials.
• In depth knowledge of industry leading eCRF tools and well versed in industry trends and emerging technologies supporting data collection.
• Proficient experience using commercial clinical data management systems and/or EDC products e.g. Medidata Rave. Must have Medidata RAVE experience.
• Strong project management; exhibit expertise in metrics analysis and reporting methodologies.
• Knowledge of clinical research, FDA & ICH, GCP, GCDMP, related regulatory requirements.
• Contribute to the growth and development of the DM team.
• Excellent verbal and written communication skills.
• Professional attitude and strong interpersonal skills.
• Ability to work well with a multi-disciplinary team of professionals.
• Flexible attitude with respect to work assignments and new learning.
• Ability to prioritize workload.
• Understanding of clinical research and the relationship of Data Management in the clinical study process.
• Strong technical aptitude and ability to adapt to multiple data management platforms.
• Strong knowledge of electronic data capture (EDC) clinical data management systems.
• Strong computer skills (Microsoft Office Suite, Medidata Rave) and ability to understand and adapt to various information technology (IT) systems.

Preferred Requirement(s):

• Working knowledge of R/R Shiny/Posit Connect or other similar tools for data quality review, reconciliation, and dashboards is a plus.

The salary range for the Senior Data Manager is expected to be between $170,000 and $190,000 per year. Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.

At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond.

As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.