The Geneva Foundation · 2 days ago
Clinical Data Manager
The Geneva Foundation is dedicated to advancing health research, and they are seeking a Clinical Data Manager to oversee data management activities across multi-site clinical research studies. This role focuses on Electronic Data Capture systems and ensures data integrity, compliance with regulatory requirements, and cross-functional collaboration with various stakeholders.
Clinical TrialsEducationNon Profit
Responsibilities
Advises on, adheres to, and completes data requirements and plans for the full data life cycle from project conception to long term data storage and usage
Design and modify Case Report Forms (CRFs) in response to IRB modifications and protocol changes
Author and execute comprehensive User Acceptance Testing (UAT) and validation testing plans to ensure database functionality
Defines data edit/validation checks, performs database lock and archive procedures, and establishes database use guidelines
Remotely monitors Clinical Trials data, confirming data accuracy and quality, and reporting to appropriate stakeholders, as needed
Perform supplemental data reviews and reconciliations to support Adverse Event (AE) and safety monitoring
Generate and track data queries; work directly with research staff to resolve any issues
Develops and maintains Data Management Plans (DMP), Standard Operating Procedures (SOPs), and Work Instructions (WI)
Assists with the design of data collection, data privacy and confidentiality plans
Cross-check EDC data against external metrics to verify accuracy and resolve discrepancies
Recommends operating methods to improve processing, distribution, data flow, collection and database editing procedures, working to optimize data quality and automate data collection and management processes
Ensures appropriate data use and/or sharing agreements are executed for each project
Consults with regulatory staff to ensure compliance with all local, federal and Department of Defense specific regulatory policies and procedures
Maintains working knowledge of all military health system data systems and resources to advise investigators on appropriate data for their research goals
Assists researchers in retrieving information from military health system databases and other data sources
Completes other projects and duties as assigned
Qualification
Required
Bachelors' degree or equivalent work experience required
3-5 years of clinical data management experience desired
Experience with Electronic Data Capture (EDC) systems, quality control, dataset creation and maintenance
Ability to investigate data quality issues and participate in remediation activities
Statistical and data analysis skills are a must to assist gathering and solving data quality issues
Experience in data writing requirements
Intermediate or advanced computer skills including Excel and other Microsoft Software
Demonstrated competence in oral and written communication
Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor
Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
Preferred
Experience using REDCap for data collection/management preferred
Excel Macros experience a plus
Company
The Geneva Foundation
The Geneva Foundation is a non-profit organization that supports medical research and in the U.S. military.
H1B Sponsorship
The Geneva Foundation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (6)
2023 (2)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Growth StageLeadership Team
Recent News
Birmingham Business Journal
2025-01-20
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