Senior Data Manager

Vor Bio•Boston, MA

2d•$170,000 - $190,000

About The Position

The Senior Data Manager is responsible for data management activities from study start-up through database lock and archiving, and independently supports clinical studies and programs of studies. The role ensures data completeness, accuracy, and consistency and supports high-quality analysis and regulatory reporting. The Senior Data Manager also contributes to continuous improvement and provides departmental leadership through mentoring and consistent study delivery. The position serves as the data lead for one or more clinical trials, overseeing internal and external data management work and collaborating with cross-functional study teams, CROs, and other vendors. It includes maintaining study documentation, supporting clinical database design and testing, ensuring data quality and inspection readiness, managing timelines and risks, and contributing to process improvements. Boston, MA is the preferred location.

Requirements

Bachelor’s degree in computer sciences, health-related sciences, or a relevant field.
At least 7 years of Data Management experience.
Hands-on, direct individual-contributor experience with all data management tasks and data management vendor oversight, delivering high-quality data on aggressive timelines.
Extensive hands-on experience with clinical data management practices in industry-sponsored clinical trials.
In-depth knowledge of leading eCRF tools, industry trends, and emerging technologies supporting data collection.
Experience with commercial clinical data management systems and/or EDC products; Medidata Rave experience is required.
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 attitude toward work assignments and 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 (EDC) 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 third-party vendors throughout the study lifecycle, from protocol synopsis through database release and submission.
Serve as a primary contact for data management partners and ensure milestones and deliverables meet quality expectations.
Ensure internal and external partners align with data management expectations for the assigned compound or indication.
Review and provide input on data management documentation, including CRF design and completion guidelines, the Data Management Plan, and data transfer specifications.
Oversee edit check specifications to support protocol-required data collection and analysis.
Ensure clinical databases adhere to CDASH guidelines to support optimal SDTM dataset programming.
Recommend standard and non-standard data collection designs, identify gaps, and challenge collection of unnecessary data.
Participate in creating the clinical development plan, including clinical development strategy and potential innovative trial designs.
Set quality expectations and timelines for data management deliverables, and follow up on milestones.
Maintain inspection readiness.
Communicate expectations clearly and transparently and motivate team members toward clinical goals.
Follow company and department SOPs, forms, templates, and policies; provide feedback and update guidance 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.
Improve the efficiency of data management tasks.
Lead and participate in intra- and interdepartmental process and quality improvement initiatives.
Contribute to the growth and development of the Data Management team.