• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $71,000 Annual - $82,000 Annual

Position Summary

The Data Manager (Pragmatic Trials – Data Coordinating Center) supports investigator-initiated, multicenter pragmatic clinical trials. Serving as the lead data management function, this role oversees data collection, quality, and integrity for all participating sites. The Data Manager ensures standardized, efficient, and compliant data workflows using real-world clinical data sources, supporting meaningful outcomes research while minimizing operational burden across sites.Enter details here

Responsibilities

• Lead centralized data coordination for investigator-initiated, pragmatic, multicenter heart failure clinical trials, overseeing data management for all collaborating sites.
• Design, build, standardize, and maintain REDCap databases across single-center and multicenter studies, ensuring databases are optimized for accurate, efficient, and proportionate data collection aligned with pragmatic trial designs.
• Develop comprehensive data management plans prior to study initiation, including data flow, submission timelines, quality checks, and reporting expectations.
• Create and maintain data dictionaries and variable definitions that prioritize clinically meaningful, feasible, and operationally sustainable endpoints.
• Perform ongoing data quality checks focused on completeness, consistency, and usability rather than exhaustive source verification; generate and manage data queries and coordinate resolution with all participating sites.
• Oversee data collection, submission, cleaning, and migration of datasets into REDCap, and prepare datasets for statistical analysis, reporting, and downstream use.
• Lead centralized data coordination for investigator-initiated, pragmatic, multicenter heart failure clinical trials, overseeing data management for all collaborating sites.
• Design, build, standardize, and maintain REDCap databases across single-center and multicenter studies, ensuring databases are optimized for accurate, efficient, and proportionate data collection aligned with pragmatic trial designs.
• Develop comprehensive data management plans prior to study initiation, including data flow, submission timelines, quality checks, and reporting expectations.
• Create and maintain data dictionaries and variable definitions that prioritize clinically meaningful, feasible, and operationally sustainable endpoints.
• Perform ongoing data quality checks focused on completeness, consistency, and usability rather than exhaustive source verification; generate and manage data queries and coordinate resolution with all participating sites.
• Oversee data collection, submission, cleaning, and migration of datasets into REDCap, and prepare datasets for statistical analysis, reporting, and downstream use.
• Train and support research coordinators and investigators on REDCap build, data entry standards, documentation expectations, and pragmatic data workflows.
• Develop, standardize, and maintain standard operating procedures (SOPs) for data collection, security, governance, and multicenter data coordination.
• Serve as a primary point of contact for site-level data questions, issue resolution, and clarification of data expectations across participating sites.
• Ensure research data management practices comply with institutional policies, IRB requirements, Data Use Agreements, and applicable regulatory standards; contribute content to Data Use Agreements for multicenter collaborations.
• Partner closely with regulatory staff to ensure alignment between study data, IRB approvals, regulatory submissions, and study documentation.
• Generate routine and ad hoc reports to support investigators, research leadership, study operations, and external stakeholders.
• Support data readiness for monitoring visits, audits, internal quality assurance reviews, and regulatory inspections.
• Assist investigators with data extraction and preparation for abstracts, manuscripts, grant reporting, and internal reviews.
• Support ClinicalTrials.gov results reporting, as applicable, in collaboration with regulatory staff and investigators.
• Contribute to the development of standardized data management templates, tools, and best practices to strengthen research infrastructure.
• Attend research operations meetings to support proactive data planning, coordination, and program development.
• Demonstrates knowledge of GCP/ICH regulations and 21 CFR Part 11
• Perform other job-related duties as assigned.

Minimum Qualifications

• Bachelor’s degree required in health sciences, public health, biology, data science, informatics, or a related field plus 4 years of related clinical research experience or equivalent combination of education and experience.
• Strong computer proficiency, including routine use of web-based systems, databases, and Microsoft Office applications (Excel, Word, Teams/SharePoint or similar).
• Effective written and verbal communication skills, with the ability to work collaboratively with investigators, coordinators, and regulatory staff.
• Strong organizational skills and attention to detail, with the ability to manage multiple studies or data streams simultaneously and meet deadlines.

Preferred Qualifications

• Demonstrated experience with clinical research data management, including electronic data capture systems (e.g., REDCap or similar platforms)
• Ability to manage data tasks independently, including database maintenance, routine data quality checks, query resolution, and report generation.
• Working knowledge of clinical research regulations and standards, including IRB requirements, human subjects protections, and data privacy/security principles (e.g., HIPAA).
• Experience using programming or query languages for data cleaning, derivation, and dataset preparation (e.g., R, SAS, SQL, Python)
• Familiarity with clinical and research data standards such as CDASH, SDTM, ADaM, and OMOP CDM

Other Requirements

• Must successfully complete applicable compliance and systems training requirements.

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.