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Clinical Data Manager

Genevausa

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Location
Bethesda, MD, United States of America
Workplace
Remote
Type
Part-time
Department
Healthcare
Seniority
Manager
Education
Bachelor
Source
Workday

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

Skills

ExcelClinical TrialsComplianceCustomer Service

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