Clinical Research Data and Analytics Manager (Hybrid)
About the Position
The Data and Analytics Manager is responsible for leading the day-to-day functions of a core Data & Analytics team providing centralized data coordination and data analysis services for a large research portfolio. Reporting to the Senior Manager of Regulatory Affairs & Data, this role directly oversees a small, dedicated team (including a Clinical Data Manager and a Data Management Analyst) supporting a robust portfolio of 65+ active multi-site research studies, including federally funded, FDA-regulated and industry-sponsored clinical trials, across military treatment facilities, academic institutions, and other sites nationwide. This position works cross-organizationally to ensure the on-time execution of high-quality and compliant research, proper documentation of procedures, accurate data reporting, and assures real-time data access for the investigator(s) and staff.
Qualifications
- Bachelor's degree in a scientific, informatics, or relevant field required.
- Master's degree, equivalent work experience, or relevant professional certification strongly preferred.
- 3-5 years' professional experience in clinical research data management, clinical trials, or a data coordinating center environment required.
- Previous research conduct experience highly desired.
- 1-2 years in team management, leadership, or direct supervisory experience required.
- Must possess a strong working knowledge of clinical research data compliance, including requirements for FDA-regulated clinical trials, IRB requirements for human subjects protections, and general best research practices.
- Must have demonstrated experience building complex, longitudinal, multi-arm electronic clinical research databases required.
- Experience using REDCap is strongly preferred.
- Must have demonstrated experience with cleaning, analyzing, and presenting real-time data and metrics.
- Must have a strong understanding of data visualization principles and the ability to build or troubleshoot business intelligence dashboards.
- Experience with PowerBI strongly preferred.
- Must have demonstrated experience executing or navigating data agreements (e.g. data use agreements, data sharing agreements, etc.) as they pertain to data privacy and security is highly desired.
- Must be organized, attentive to details, and possess an exceptional diplomatic and professional communication skills.
- Must have the ability to successfully build relationships with key stakeholders and to effectively communicate requirements for data and analytics systems as well as translate technical data requirements to non-technical stakeholders.
- Must thrive in a fast-paced environment with shifting priorities, multiple moving targets, and strict timelines.
Job Responsibilities
- Ensure data capture, management, sharing, and analysis compliance of assigned research.
- Maintain oversight of data management and analysis needs across a large portfolio of clinical research studies, effectively delegating tasks and tracking project timelines.
- Lead and mentor a team of data professionals.
- Act as a hands-on backstop to execute technical tasks (e.g., database builds, QC cycles, dashboard creation) during team absences or high-volume periods to ensure strict adherence to deadlines.
- Contribute to the development, refinement, standardization, and dissemination of clinical data management workflows, SOPs, and cross-functional processes within the broader research program.
- Serve as the primary representative and subject matter expert (SME) for the Data & Analytics Team in high-level meetings with a diverse mix of stakeholders, including program leadership, institutional leadership, partners, and industry sponsors.
- Partner with study investigators and external collaborators to provide expert guidance on data collection strategies, data entry protocols, monitoring/QC plans, and data sharing requirements.
- Participate in early-stage study development meetings to align data strategies with protocol requirements prior to execution.
- Review and advise on the development of Case Report Forms (CRFs) for compliance, data integrity, and database compatibility, providing formal endorsement prior to IRB submission.
- Oversee the drafting, application, and compliance management of Data Sharing Agreements (DSAs) and Data Use Agreements (DUAs).
- Direct and participate in rigorous QC cycles to identify analytical anomalies and protect against the exposure of PII/PHI within research databases.
- Support the translation of raw research data into knowledge products, including data analysis for manuscripts, abstracts, and statistical tables.
- Oversee the design and maintenance of real-time study visualization dashboards to provide stakeholders with clear enrollment and study outcome insights.
- Promote safety and confidentiality of research participants at all times.