Senior Data Manager

Vor Bio•Boston, MA

2d•$170,000 - $190,000

About The Position

The Senior Data Manager leads data management activities for one or more clinical trials from study start-up through database lock, release, and archiving. The role independently supports clinical studies and study programs, ensuring data completeness, accuracy, consistency, and quality suitable for analysis, reporting, and regulatory submissions. It also includes oversight of CROs and other third-party vendors, collaboration with cross-functional teams, and responsibility for inspection readiness and timely, high-quality deliverables. The Senior Data Manager contributes to continuous process improvement and departmental leadership, including mentoring and supporting the development of team members. The preferred location is Boston, Massachusetts. Vor describes its work as advancing telitacicept, a dual BAFF/APRIL inhibitor, for autoimmune diseases.

Requirements

Bachelor’s degree in computer sciences, health-related sciences, or a relevant field.
At least 7 years of data management experience.
Hands-on individual-contributor experience with data management tasks and vendor oversight to deliver high-quality data within aggressive timelines.
Extensive hands-on experience with clinical data management practices in industry-sponsored clinical trials.
In-depth knowledge of leading eCRF tools and industry trends and emerging technologies for data collection.
Experience with commercial clinical data management systems or EDC products, including required Medidata Rave experience.
Strong project management skills and expertise in metrics analysis and reporting methodologies.
Knowledge of clinical research, FDA and ICH requirements, GCP, GCDMP, and related regulatory requirements.
Excellent verbal and written communication skills.
Professional attitude and strong interpersonal skills.
Ability to work effectively with a multidisciplinary team.
Flexible approach to work assignments and new learning.
Ability to prioritize workload.
Superior attention to detail.
Understanding of clinical research and the role 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 and clinical data management systems.
Strong computer skills, including Microsoft Office Suite and Medidata Rave, and ability to understand and adapt to various IT systems.

Nice To Haves

Working knowledge of R, R Shiny, Posit Connect, or similar tools for data quality review, reconciliation, and dashboards.

Responsibilities

Serve as data lead for one or more clinical trials and oversee all data management activities, including access levels and permissions.
Drive quality and efficiency to meet data management timelines and milestones in collaboration with cross-functional study teams.
Oversee data management activities performed internally and by CROs and other third-party vendors, including IRT, safety, and laboratory vendors, throughout the study lifecycle.
Serve as a primary point of contact for data management partners and help ensure milestones and deliverables meet quality expectations.
Ensure internal and external partners align with data management expectations for assigned compounds or indications.
Review and provide input on data management documentation, including CRF design and completion guidelines, Data Management Plans, and Data Transfer Specifications.
Oversee edit check specifications to support protocol-required data collection and analysis.
Ensure clinical databases follow CDASH guidelines and support optimal SDTM programming; recommend standard and non-standard data collection designs, identify data collection gaps, and challenge unnecessary collection.
Participate in creating the clinical development plan, including clinical development strategy and potential innovative trial designs.
Set data management quality expectations and timelines, track milestones, and maintain inspection readiness.
Communicate expectations clearly, motivate team members, and support achievement of clinical goals.
Follow company and departmental SOPs, forms, templates, and policies; provide feedback and update guidelines as needed.
Develop, review, and maintain study data management documentation.
Guide quality control review and user acceptance testing of clinical databases before production release, including oversight of staff performing these tasks.
Ensure data are reviewed according to the Data Management Plan and guidelines, and that data cleaning is effective and timely.
Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager.
Identify opportunities to improve the efficiency of data management tasks.
Lead and participate in departmental and cross-functional process and quality improvement initiatives.
Contribute to the growth and development of the Data Management team.