Clinical Data Manager

The Geneva Foundation•Bethesda, MD

About The Position

The Clinical Data Manager supports the coordination of multi-site study protocols through electronic data capture (EDC) system management, design and testing, data-query development and execution, and data-sharing agreements. The role works across organizations to ensure data quality, resolve discrepancies, comply with regulatory requirements, and document standard operating procedures. It oversees quality assurance for study databases, proactively tests for data-integrity issues, and recommends and plans solutions based on research goals. The position supports the full data life cycle, from project conception through long-term storage and use. It designs and modifies case report forms, develops and executes database testing plans, establishes validation checks and database-use guidelines, and performs database locking and archiving. It also remotely monitors clinical-trial data, supports adverse-event and safety reviews, and works with research staff and stakeholders to address issues. The Clinical Data Manager develops and maintains data-management plans, procedures, and work instructions; supports data collection, privacy, and confidentiality planning; verifies EDC data against external metrics; and recommends improvements to data-processing and management workflows. The role also supports appropriate data use and sharing, consults with regulatory staff regarding applicable policies, maintains working knowledge of military health system data resources, and assists researchers with retrieving data. Travel for business may be required.

Requirements

Bachelor’s degree or equivalent work experience.
Experience with Electronic Data Capture (EDC) systems, quality control, and dataset creation and maintenance.
Ability to investigate data-quality issues and participate in remediation activities.
Statistical and data-analysis skills to assist in gathering information about and resolving 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.
Organized, attentive to detail, and able to maintain a positive, friendly, and professional demeanor.
Flexible with changing priorities and able to communicate diplomatically and professionally.
Physically able to move freely or remain stationary for prolonged periods.
Valid state driver’s license and access to reliable transportation.
Willingness to travel for business as required.

Nice To Haves

Three to five years of clinical data management experience.
Experience using REDCap for data collection and management.
Experience with Excel Macros.

Responsibilities

Oversee quality assurance of study databases, proactively test data for integrity issues, and recommend and plan solutions based on research goals.
Advise on, adhere to, and complete data requirements and plans throughout the data life cycle, from project conception to long-term storage and use.
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 to ensure database functionality.
Define data edit and validation checks, perform database lock and archive procedures, and establish database-use guidelines.
Remotely monitor clinical-trial data for accuracy and quality and report findings to appropriate stakeholders as needed.
Perform supplemental data reviews and reconciliations to support adverse-event 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 to verify accuracy and resolve discrepancies.
Recommend methods to improve processing, distribution, data flow, collection, and database-editing procedures, and help optimize data quality and automate data collection and management.
Ensure appropriate data-use and data-sharing agreements are executed for each project.
Consult with regulatory staff to ensure compliance with local, federal, and Department of Defense regulatory policies and procedures.
Maintain working knowledge of military health system data systems and resources and advise investigators on appropriate data for research goals.
Assist researchers in retrieving information from military health system databases and other data sources.
Complete other projects and duties as assigned.
Maintain and promote The Geneva Foundation’s core values and working knowledge of applicable employee guidance and standard operating practices.
Remain accessible and accountable during work hours, collect messages at least twice daily, and return telephone messages within one business day and emails in a timely manner.
Comply with the dress code and promote positive, professional relationships with coworkers.