Senior Data Manager

vorbiopharma; Boston (MA); On-site; USD 110,000 - 165,000; Full time

Job summary

Vor is seeking a Senior Data Manager to lead data management activities from start-up through database lock, ensuring accuracy and consistency while meeting regulatory standards. The role includes mentoring, process improvement, and cross-functional collaboration to deliver high-quality data for multiple studies.

You will oversee internal teams and external vendors, drive quality, and maintain documentation and timelines to support efficient clinical development and timely submissions.

Qualifications

• Bachelor's Degree in computer sciences, health-related sciences, or relevant field; 7+ years DM experience.
• Hands-on experience with data management tasks and DM vendor oversight.
• Extensive experience with clinical data management within industry-sponsored trials.

Responsibilities

• Serve as data lead for one or more clinical trials with full data management ownership.
• Drive quality and efficiency to meet timelines in collaboration with cross-functional study teams.
• Oversee data management activities by CROs and third-party vendors to meet obligations.
• Be the first DM point of contact to ensure milestones and deliverables are met with high quality.
• Ensure alignment with data management expectations for the assigned compound/indication.
• Review DM documentation (CRF design, DMP, Data Transfer Specifications).
• Oversee edit check specifications to support data collection and analysis per protocol.
• Ensure the clinical database adheres to CDISC SDTM standards and guides data collection.
• Contribute to clinical development plans and potential innovative trial designs.
• Set milestones and timelines for DM deliverables and ensure readiness for inspections.

Skills

Data management

Project coordination

Quality control

SOP adherence

Education

Bachelor's degree in computer sciences/health-related sciences

Tools

Clinical data management systems

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.

Why Work at Vor?

• 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.

Location: Boston, MA preferred

The Senior Data Manager is responsible for all 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. The Senior Data Manager will ensure completeness, accuracy and consistency and meet the standards of quality analysis and reporting to regulatory bodies. In addition, the Senior Data Manager has an active role in continuous improvement and acts as a leader in the department as demonstrated by 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 cycle i.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 motive 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 intradepartmental 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 sponsore