GENERAL SUMMARY:Design & develop data collection forms/electronic case report forms, data management plans, data cleaning and data corrections for research study protocols.Test and validate study-specific electronic data capture (EDC) systems.Create and maintain REDCap (or other EDC) databases including efficient electronic data capture, the organization and management of all data, the creation and updating of queries and reports, and interfacing between REDCap and other data management systems using API and related methods.Develop programs to check the integrity of the data including range, error, and logic checks.Run queries to verify data quality on regular basis.Generate and prepare reports on the quantity and quality of data in the data management system.Retrieve data and generate reports from the database as requested by PIs, sponsors, or senior staff.Manage Data Use Agreements (DUAs).Develop user training course materials and serve as contact point for site users.Performs advanced and routine data quality assurance.Develop and oversee processes for data cleaning, storage, quality checks, and reporting.Develop programs to check the integrity of the data, including range, error, and logic checks.Preparing reports on the quantity of data and quality in the data management system.Prepare reports (enrollment, adverse events, data quality) for submission to the Institutional Review Board (IRB), study sites, or regulatory agencies as needed.Attend/conduct meetings, teleconferences, and webinars relevant to current or upcoming research and clinical projects.Consider both back-end organization of data and front-end accessibility for end users and applications.Serve as a REDCap super user who can train CCI staff and clinical site study staff on REDCap (or other EDC system).Review the work of data entry staff and serve as their point of escalation for data quality issues.Ensure 21 CFR Part 11 Compliance procedures are followed (as applicable per each study), may also be responsible for developing and maintaining 21 CFR Part 11 Compliance documents.Manage project timelines.Participate and contribute at research meetings, may include developing agendas, leading meetings, summarizing meeting discussions.Maintain department service standards as outlined in the BWH Code of Conduct.Other duties as requested by the Director of the CTCC, Manager of the DMC, or other senior members of the CCI.Qualifications
The Center for Clinical Investigation (CCI) is designed to provide infrastructure support to the investigative community, leading to a more effective and robust clinical research enterprise at Brigham and Women's Hospital.
The Research Data Manager will work within the CCI's Data Management Core (DMC) and/or Clinical Trial Coordinating Center (CTCC) to perform the following duties as assigned: oversee database design, data collection, and data quality monitoring and management for large multi-center clinical trials. Develop case report forms, develop and generate study reports, setup and perform data quality checks, perform data cleaning/extraction, and manage trial-specific databases in the CTCC/DMC.
Qualified candidates will have a Bachelor's degree with a MPH or MS preferred, preferably in Public Health, Applied Math, Computer Science, Economics, Epidemiology, Statistics, or a related quantitative field and experience in data collection, database management, data audits, or data cleaning. Experience with REDCap and/or clinical research a plus.
PRINCIPAL DUTIES & RESPONSIBILITIES:
- Bachelor's degree required, MPH or MS degree preferred, preferably in Public Health, Applied Math, Computer Science, Economics, Epidemiology, Statistics, or a related quantitative field
- High proficiency with Microsoft Office, particularly with Word, Excel, PowerPoint
- Experience implementing data management plans, data cleaning procedures, or data audits for clinical trials
- Working knowledge of SAS, STATA, or R as well as advanced mastery of statistical analyses
- Strong programming experience with a scripting language like Python or Matlab
- Experience or familiarity with REDCap, git/GitHub/GitLab, DevOps, CI/CD, and other data pipelining practices, preferred
- 3-5 years of related experience in data collection, database management, data audits, data cleaning, running reports, etc.
- Must have strong organizational skills, with the ability to focus detailed concentrated efforts to multiple projects and re-establish priorities as necessary;
- Excellent attention to detail that ensures follow through on all initiatives implemented, and all projects undertaken;
- Ability to effectively respond to time sensitive issues and meet deadlines;
- Must demonstrate sound independent judgement regarding data management;
- Must have excellent verbal and written communication skills;
- Ability to learn new software/database technologies quickly;
- Ability to troubleshoot situations and escalate issues as needed;
- Ability to work independently (self-direction), while thriving in a setting requiring collaboration and teamwork;
- Ability to prioritize assignments, multi-task, make decisions based upon sound principles, and independently problem solve;
- Must maintain a high level of patient and data confidentiality and security.
- Experience developing electronic case report forms;
- Experience with REDCap, StudyTrax, and/or MS Access;
- Experience using an API with an Electronic Data Capture (EDC) system;
- Working knowledge of 21 CFR Part 11 regulations;
- Clinical research experience;
- Customer service experience in a research setting, healthcare environment, or consultancy.
- Familiarity with one or more of the following:
- One or more scripting languages (Python, Matlab, csh, etc.)
- Statistics processing software (SPSS, R, etc.)
- Healthcare experience, particularly in an academic medical setting, a plus
- Familiarity with EPIC, RStudio, GitHub, a plus
Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.