Clinical Research Data Manager I — REDCap & Data Quality

Tufts Medical Center, Inc.; United States; On-site; USD 56,000 - 70,000; Full time

Job summary

Tufts Medicine's Center for Clinical Trials at Tufts CTSI seeks a Clinical Research Data Manager I to join a collaborative data management team. You will support operationalization of trial protocols into high-quality electronic data systems, with hands-on REDCap and EDC build/testing, data quality control, and query resolution.

The role emphasizes meticulous execution, adherence to GCP and FDA requirements, and coordination with investigators, biostatisticians, and project managers to deliver

Qualifications

• Bachelor's degree in health science, public health, epidemiology or related field.
• 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.

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 SOPs, GCP 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.

Skills

REDCap

EDC

GCP

FDA regs

SQL

SAS

Data management

Education

Bachelor's degree in health science/public health/epidemiology/biostatistics or related

Tools

SAS

SQL

REDCap

Job description

Tufts Medicine's Center for Clinical Trials at Tufts CTSI seeks a Clinical Research Data Manager I to join a collaborative data management team. You will support operationalization of trial protocols into high-quality electronic data systems, with hands-on REDCap and EDC build/testing, data quality control, and query resolution.

The role emphasizes meticulous execution, adherence to GCP and FDA requirements, and coordination with investigators, biostatisticians, and project managers to deliver