Clinical Research Data Manager I

Tufts Medicine•Boston, MA

About The Position

This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Programs and Projects duties: Supports the development of new products and innovation. Includes Clinical roles focused on research projects. Positions in this family perform basic, translational, and/or clinical research towards solving a specific problem for an entity or community. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. A senior level role that requires advanced knowledge of job area typically obtained through advanced education and work experience. Typically responsible for: managing projects / processes, working independently with limited supervision, coaching and reviewing the work of lower level professionals, resolving difficult and sometimes complex problems. 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 will be an integral member of the data management team, working closely with principal investigators, senior data manager, project managers, and biostatisticians to support the operationalization of clinical trial protocols into high-quality electronic data systems. This role requires hands-on proficiency with REDCap and core clinical trial data management workflows. The Data Manager will work within established data coordinating center processes to support protocol-driven database design, REDCap EDC build and testing (including branching logic, calculated fields, and automated notifications), and ongoing data quality control activities. The position emphasizes rigorous execution, attention to detail, and accountability for assigned day-to-day data management tasks, including supporting query resolution, data cleaning, and assisting with the preparation of analysis-ready datasets in compliance with GCP and institutional standards.

Requirements

Bachelor’s degree in health science, public health, epidemiology, or another related field including coursework in biostatistics or computerized analytic techniques.
Three (3) 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, Electronic Data Capture (EDC) and industry data standards (e.g., CDISC).
Proven capability of attention to detail and accuracy.
Knowledge of GCP guidelines and FDA regulations.
Ability 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.
Proficiency in other data management and statistical software (e.g, SAS, SQL, web based EDC) is desirable.

Nice To Haves

Experience assisting in the build and management of REDCap databases
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 the preparation of analysis-ready datasets and collaborating closely with biostatisticians

Responsibilities

Develops Electronic Case Report Forms, eCRF completion guidelines and edit checks, and trial Data Management Plans.
Communicates with trial site staff regarding data submission and the resolution of data queries, and performing descriptive statistical analyses.
Leads daily data activities for assigned studies.
Designs, develops, tests, validates, and manages Web-based EDC systems to support study outcomes.
Writes and implements 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.
Supports clinical research reporting for data review, quality-control edit checks, and interim and final analyses.
Completes database cleaning and database locks, and assisting research biostatisticians with analysis file creation and statistical analyses.
Provides educational support and training to investigators and study site coordinators for the development and implementation of research studies.
Mentors data management/entry staff and providing project management support.
Serves as credible expert/leader for data management best practices.
Establishes priorities and strategies for resource development and core goal setting.
Provides positive and effective customer service and contributing to teamwork within and between departments, divisions, programs and other organizations.
Ensures work is performed in conformance with established hospital, program, federal, and state policies and procedures.