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Clinical Data Manager
The Geneva Foundation. Support coordination of multi-site study protocols through EDC system management, design and testing, data query development and execution, and data sharing agreements .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Data Management, including Electronic Data Capture (EDC) systems, data quality assurance, and regulatory compliance. Proficient in developing Data Management Plans (DMPs) and executing User Acceptance Testing (UAT) while maintaining effective communication and collaboration with stakeholders.
Highest-signal resume keywords
Clinical Data Management ExperienceElectronic Data Capture (EDC) SystemsData Quality AssuranceUser Acceptance Testing (UAT)Statistical and Data Analysis Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data Query DevelopmentCase Report Forms (CRFs) DesignData Validation ChecksDatabase Lock ProceduresData Management Plans (DMPs)Standard Operating Procedures (SOPs)Data Writing RequirementsExcel MacrosStatistical AnalysisData Reconciliation
Soft Skills
Oral and Written CommunicationAttention to DetailOrganizational SkillsFlexibility with Changing PrioritiesProfessional Demeanor
Tools & Technologies
REDCapMicrosoft ExcelElectronic Data Capture (EDC) Systems
Industry Keywords
Regulatory ComplianceData IntegrityAdverse Event (AE) MonitoringMilitary Health System DataData Privacy
About the role
Key responsibilities & impact- Support coordination of multi-site study protocols through EDC system management, design and testing, data query development and execution, and data sharing agreements
- Ensure data quality, resolve data discrepancies, confirm adherence to stringent regulatory requirements, and document standard operating procedures
- Oversee quality assurance of study databases and proactively identify data integrity issues
- Advise on and complete data requirements and plans across the full data lifecycle
- Design and modify Case Report Forms (CRFs) in response to IRB modifications and protocol changes
- Author and execute User Acceptance Testing (UAT) and validation testing plans
- Define data edit and validation checks; perform database lock and archive procedures; establish database use guidelines
- Remotely monitor clinical trial data for accuracy and quality and report to stakeholders
- Perform supplemental data reviews and reconciliations for Adverse Event (AE) and safety monitoring
- Generate and track data queries and work with research staff to resolve issues
- Develop and maintain Data Management Plans (DMPs), Standard Operating Procedures (SOPs), and Work Instructions (WIs)
- Assist with data collection, data privacy, and confidentiality plans
- Cross-check EDC data against external metrics and resolve discrepancies
- Improve processing, distribution, data flow, collection, and database editing procedures; optimize data quality and automate processes
- Ensure data use and sharing agreements are executed
- Consult with regulatory staff regarding local, federal, and Department of Defense policies and procedures
- Maintain working knowledge of military health system data systems and resources
- Assist researchers in retrieving information from military health system databases and other data sources
- Complete other assigned projects and duties
- Maintain organizational core values, follow applicable policies and procedures, remain accessible during work hours, respond to messages, comply with dress code, and promote professional coworker relationships
Requirements
What you’ll need- 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
- 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
- Organized, attentive to detail, and positive, friendly and professional demeanor
- Flexible with changing priorities and able to communicate in a diplomatic and professional manner
- Valid state driver’s license and access to reliable transportation
- Willingness to travel for business as required
- Physically able to move freely or be stationary for prolonged periods of time
Benefits
Comp & perks- Hybrid work arrangement: 2 days remote / 3 days in office
- Part-time employment
- Exempt status