- Department: Clinical and Translational Science Institute (CTSI)
- Schedule: Full Time
- Shift: Days
- Hours: 8:30-5:00
- Location: Tufts Medical Center
Tufts CTSI seeksan experienced Clinical Data Manager to partner with Project Managers, Principal Investigators and Study Statisticians on the design, functionality, development, implementation, and validation of relational databases for single and multicenter clinical trials.
Developing Electronic Case Report Forms, eCRF completion guidelines and edit checks, and trial Data Management Plans.
Communicating with trial site staff regarding data submission and the resolution of data queries, and performing descriptive statistical analyses.
Leading daily data activities for assigned studies.
Designing, developing, testing, validating, and managing Web-based EDC systems to support study outcomes.
Writing/implementing data management plans, data entry guidelines, and data completion guidelines in compliance with Standard Operating Procedures, Good Clinical Practice (GCP) guidelines, and FDA requirements, if applicable.
Supporting clinical research reporting for data review, quality-control edit checks, and interim and final analyses.
Completing database cleaning and database locks, and assisting research biostatisticians with analysis file creation and statistical analyses.
Providing educational support and training to investigators and study site coordinators for the development and implementation of research studies.
Mentoring data management/entry staff and providing project management support.
Serving as credible expert/leader for data management best practices.
Establishing priorities and strategies for resource development and core goal setting.
Providing positive and effective customer service and contributing to teamwork within and between departments, divisions, programs and other organizations.
Ensuring work is performed in conformance with established hospital, program, federal, and state policies and procedures.
Bachelor’s degree in health science, public health, epidemiology, or closely related field, including coursework in biostatistics or computerized analytic techniques.
3-5 years of experience as a clinical data manager and with developing relational databases for clinical studies using REDCap and/or commercially available EDC systems is required
Knowledge of, and high proficiency in, Electronic Data Capture (EDC) and industry data standards (e.g., CDISC). Proficiency in other data management and statistical software (e.g, SAS, SQL, web based EDC) is desirable.
Proven capability of attention to detail and accuracy.
Knowledge of GCP guidelines and FDA regulations.
Able to maintain positive and service-oriented culture under stress and deadlines.
Flexible and able to adjust to shifting priorities in a fast-paced and dynamic work environment.
Superior organizational skills: can prioritize and complete multiple simultaneous efforts with ease.
Ability to work independently and as a part of a collaborative team.
Knowledge of clinical and translational research is desirable.
Tufts Clinical and Translational Science Institute (CTSI) (www.tuftsctsi.org/), one of more than 50 organizations supported by the National Institutes of Health (NIH) Clinical and Translational Science Awards (CTSAs), was established in 2008 to transform the biomedical research process through education, promoting collaboration, and the provision of research infrastructure and support services. Tufts CTSI accelerates the translation of laboratory research into clinical use, medical practice, and health policy. In addition to its work with Tufts University, Tufts Medical Center, and other partner organizations, Tufts CTSI contributes to the national CTSA Consortium.