Clinical Research Data Manager I

tuftsmedicine; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

The Center for Clinical Trials at Tufts CTSI and Tufts Medical Center is seeking a Clinical Research Data Manager I to convert protocols into high-quality REDCap-based data systems. The role emphasizes data quality, adherence to GCP and FDA guidelines, and collaboration with investigators and statisticians.

You will build and test EDC workflows, manage data queries, and support analysis-ready datasets while mentoring junior staff and aligning with center standards.

Qualifications

• Bachelor's degree in health science, public health, epidemiology, or related field with biostatistics coursework.
• 3 years of experience as a clinical data manager with REDCap or EDC systems.

Responsibilities

• Develops electronic case report forms, eCRF guidelines and edit checks.
• Communicates with trial site staff on data submission and queries.
• Leads daily data activities for assigned studies.
• Designs and tests Web-based EDC systems to support study outcomes.
• Writes data management plans and guidelines in line with SOPs and GCP.
• Supports data review, quality control and interim/final analyses.
• Performs database cleaning and locks; assists with analysis file creation.
• Provides training to investigators and site coordinators.
• Mentors data management staff and supports project management.
• Leads in data management best-practice discussions.
• Sets priorities and strategies for resource development.
• Collaborates across departments and programs.

Skills

Clinical data management

Data quality control

Mentoring

Project coordination

Education

Bachelor's degree in health science, public health, epidemiology, or related field with biostatistics coursework

Tools

REDCap

EDC systems

Job description

Job Overview

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.

Job Profile Summary

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.

Job Description

Minimum Qualifications:

1. 1. Bachelor's degree in health science, public health, epidemiology, or another related field including coursework in biostatistics or computerized analytic techniques.
2. 2. 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.

Preferred Qualifications:

1. 1. Five (5) years of experience as a clinical data manager including developing relational databases for clinical studies using REDCap and/or commercially available EDC systems.
2. 2. Experience translating protocols into schedules of events, CRFs, and database specifications
3. 3. Experience supporting data quality control, query generation and resolution, and database cleaning and lock, under supervision
4. 4. Experience assisting with the preparation of analysis-ready datasets and collaborating closely with biostatisticians

Duties and Responsibilities:

The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.

1. 1. Develops Electronic Case Report Forms, eCRF completion guidelines and edit checks, and trial Data Management Plans.
2. 2. Communicates with trial site staff regarding data submission and the resolution of data queries, and performing descriptive statistical analyses.
3. 3. Leads daily data activities for assigned studies.
4. 4. Designs, develops, tests, validates, and manages Web-based EDC systems to support study outcomes.
5. 5. 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.
6. 6. Supports clinical research reporting for data review, quality-control edit checks, and interim and final analyses.
7. 7. Completes database cleaning and database locks, and assisting research biostatisticians with analysis file creation and statistical analyses.
8. 8. Provides educational support and training to investigators and study site coordinators for the development and implementation of research studies.
9. 9. Mentors data management/entry staff and providing project management support.
10. 10. Serves as credible expert/leader for data management best practices.
11. 11. Establishes priorities and strategies for resource development and core goal setting.
12. 12. Provides positive and effective customer service and contributing to teamwork within and between departments, divisions, programs and other or