Clinical Data Manager

The Geneva Foundation
  • Bethesda, Maryland
    2 days ago

    Job Description

    REPORTS TO: Data & Analytics Manager, Geneva Manager and/or their designee
    OVERVIEW: The Clinical Data Manager will support the coordination of multi-site study protocols
    through Electronic Data Capture (EDC) system management, design and testing, development
    and execution of data queries, as well as data sharing agreements. This position works crossorganizationally to ensure data quality, resolve data discrepancies, confirm data management
    practices adhere to stringent regulatory requirements, and document standard operating
    procedures.
    DATE: 23 December 2025
    FLSA STATUS: Exempt
    Principle duties and responsibilities include, but are not limited to, the following

    QUALIFICATIONS

    • 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

    • Experience using REDCap for data collection/management preferred

    • 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

    • Excel Macros experience a plus

    • 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

    MANAGEMENT RESPONSIBILITIES

    • Oversees quality assurance of all study databases, proactively tests data to identify data

    integrity issues, makes recommendations, and plans solutions based on research goals

    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

    PROFESSIONAL RESPONSIBILITIES

    • Maintain and promote The Geneva Foundation’s core values of Integrity, Superior

    Customer Service, Quality, Teamwork, Innovation, and Respect for All

    • Possess a working knowledge of The Geneva Foundation’s Employee Handbook, User’s

    Guide, and Standard Operating Practices (SOPs) as applicable

    • Remain accessible and accountable at all times during work hours and collect messages

    at least twice daily

    Return telephone messages within one business day of receipt; return email messages in

    a timely manner as appropriate

    • Comply with the dress code of The Geneva Foundation and assigned duty station

    • Promote positive, professional relationships with co-workers at The Geneva Foundation

    WORK QUALIFICATIONS, WORKING CONDITIONS, AND TRAVEL

    • Physically able to move freely or be stationary for prolonged periods of time

    • Must possess a valid state driver’s license and access to reliable transportation

    • Must be willing to travel for business as required

    • May be required to work in confined spaces and share office space with others

    DISCLAIMER

    The above is not intended to be an all-inclusive list of requirements and essential functions for the

    job described, but rather a general description of some of the responsibilities necessary to carry

    out the duties of this position. Employees occupying this position may be required to follow other

    job-related instructions, and to perform other job-related duties as requested by their supervisor.

    Furthermore, this does not establish a contract for employment and is subject to change at the

    discretion of the employer.

    ACKNOWLEDGEMENT OF RECEIPT OF JOB DESCRIPTION

    I acknowledge that I have received a copy of this job description. I understand the duties; am fully

    able to meet the requirements; and will perform the essential functions of this position, with or

    without reasonable accommodations. I further acknowledge and understand that this job

    description does not create an employment contract and nothing contained herein alters my atwill employment status.

    Signature

    Numbers & Facts

    LocationBethesda, Maryland

    Skills

    • Acceptance Testingunmatched
    • Adverse Eventsunmatched
    • Analysis Skillsunmatched
    • Case Report Form (CRF)unmatched
    • Clinical Dataunmatched
    • Clinical Data Managementunmatched
    • Clinical Monitoringunmatched
    • Clinical Trialunmatched
    • Communication Skillsunmatched
    • Computer Skillsunmatched
    • Consultingunmatched
    • Customer Service Evaluationunmatched
    • Data Analysisunmatched
    • Data Collectionunmatched
    • Data Managementunmatched
    • Data Qualityunmatched
    • Data Setsunmatched
    • Data Storageunmatched
    • Documentation Standardsunmatched
    • Driver's Licenseunmatched
    • Electronic Data Capture (EDC)unmatched
    • IRB/IEC (Institutional Review Board/Independent Ethics Committee)unmatched
    • Maintain Complianceunmatched
    • Metricsunmatched
    • Microsoft Excelunmatched
    • Microsoft Product Familyunmatched
    • Militaryunmatched
    • Organizational Skillsunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Procedure Developmentunmatched
    • Quality Assuranceunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Reconciliationunmatched
    • Regulationsunmatched
    • Regulatory Requirementsunmatched
    • Requirements Managementunmatched
    • Research Protocolsunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Statisticsunmatched
    • Systems Administration/Managementunmatched
    • Team Playerunmatched
    • Test Designunmatched
    • Test Plan/Scheduleunmatched
    • Testingunmatched
    • Time Managementunmatched
    • Validation Testingunmatched
    • Willing to Travelunmatched
    • Writing Skillsunmatched

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