Clinical Research Data Manager I

Tufts Medicine•Boston, MA

24d•$55,883 - $69,860

About The Position

The Center for Clinical Trials at Tufts CTSI and Tufts Medical Center is an academic data coordinating center supporting investigator-initiated multisite clinical trials. The Clinical Research Data Manager I works with principal investigators, senior data managers, project managers, and biostatisticians to operationalize clinical trial protocols in high-quality electronic data systems. The role supports protocol-driven database design, REDCap EDC development and testing—including branching logic, calculated fields, and automated notifications—and ongoing data quality control. It involves carrying out assigned day-to-day data management tasks, supporting query resolution and data cleaning, and helping prepare analysis-ready datasets in accordance with GCP and institutional standards. The position performs research and development work supporting research programs and projects, including clinical research. It applies specialized knowledge to processes and programs and may direct the work of lower-level professionals or manage processes and programs. The role develops and manages clinical study data systems and documentation, supports study sites and investigators, and contributes to reporting, data review, database locks, and analysis preparation. Work is performed in conformance with applicable hospital, program, federal, and state policies and procedures. The position is largely sedentary and requires frequent communication and use of computer equipment. The pay range is $55,883.46–$69,859.61, based on full-time equivalent. Tufts Medicine describes its Total Rewards package as supporting health, financial security, and career growth.

Requirements

Bachelor’s degree in health science, public health, epidemiology, or a related field, including coursework in biostatistics or computerized analytic techniques.
Three years of experience as a clinical data manager, including developing relational databases for clinical studies using REDCap and/or commercially available EDC systems.
Analytical skills.
Knowledge of and high proficiency in EDC and industry data standards such as CDISC.
Attention to detail and accuracy.
Knowledge of GCP guidelines and FDA regulations.
Ability to maintain a positive, service-oriented culture under stress and deadlines.
Flexibility to adjust to shifting priorities in a fast-paced, dynamic work environment.
Strong organizational skills, including the ability to prioritize and complete multiple simultaneous efforts.
Ability to work independently and collaboratively as part of a team.
Knowledge of clinical and translational research.

Nice To Haves

Five years of experience as a clinical data manager, including developing relational databases for clinical studies using REDCap and/or commercially available EDC systems.
Experience translating protocols into schedules of events, CRFs, and database specifications.
Experience supporting data quality control, query generation and resolution, and database cleaning and lock under supervision.
Experience assisting with preparation of analysis-ready datasets and collaborating closely with biostatisticians.
Proficiency in other data management and statistical software, such as SAS, SQL, or web-based EDC systems.

Responsibilities

Develop electronic case report forms (eCRFs), eCRF completion guidelines, edit checks, and trial data management plans.
Communicate with trial site staff about data submission and resolution of data queries, and perform descriptive statistical analyses.
Lead daily data activities for assigned studies.
Design, develop, test, validate, and manage web-based EDC systems to support study outcomes.
Write and implement data management plans, data entry guidelines, and data completion guidelines in compliance with SOPs, GCP guidelines, and FDA requirements where applicable.
Support clinical research reporting for data review, quality-control edit checks, and interim and final analyses.
Complete database cleaning and database locks, and assist research biostatisticians with analysis file creation and statistical analyses.
Provide educational support and training to investigators and study site coordinators for the development and implementation of research studies.
Mentor data management and data entry staff and provide project management support.
Serve as a credible expert and leader for data management best practices.
Establish priorities and strategies for resource development and core goal setting.
Provide positive, effective customer service and contribute to teamwork within and between departments, divisions, programs, and other organizations.
Ensure work conforms to established hospital, program, federal, and state policies and procedures.