Manager, EDC Administration

Accountabilities:
The Manager, EDC Administration will lead and support the administration of clinical data management systems while ensuring compliance, quality, and operational efficiency across clinical studies. Serve as the lead administrator for electronic data capture (EDC) systems supporting clinical studies in the United States. Manage user access, site setup, local laboratory range uploads, subject administration, and site numbering activities across EDC platforms. Support integrations between EDC systems and other clinical platforms, including clinical trial management systems, interactive response technologies, and master data management solutions. Perform quality control reviews of administrative activities to ensure accuracy, consistency, and compliance with applicable standards. Create, maintain, and manage documentation supporting EDC administration activities, including procedures, work instructions, templates, and system records. Assist with the development and improvement of standard operating procedures and operational guidelines. Support testing activities for external data loads, custom reports, system integrations, and EDC builds. Coordinate and support audit activities, ensuring documentation readiness and timely resolution of findings. Supervise and coordinate the work of EDC administrators, providing guidance and operational oversight. Collaborate with cross-functional clinical teams to ensure systems support efficient and compliant trial execution. Contribute to continuous improvement initiatives related to clinical systems, workflows, and data management processes. Requirements: The ideal candidate will bring strong clinical systems expertise, experience in regulated environments, and the ability to collaborate across multidisciplinary teams supporting clinical research programs. Master’s degree in Computer Science, Engineering, or a closely related field with at least 5 years of relevant experience, or a Bachelor’s degree in a related field with at least 7 years of relevant experience. Hands-on experience administering clinical systems such as Medidata Rave, Oracle Inform, or Oracle Clinical Trial Management Systems. Experience supporting clinical data warehouse solutions and enterprise clinical technology environments. Proven ability to create and maintain SOPs, work instructions, templates, and compliance documentation. Experience using ticketing and workflow management systems such as Jira and ServiceNow. Experience collaborating with pharmaceutical or biotechnology cross-functional teams, including Clinical Operations, Safety, and Biometrics. Strong understanding of clinical trial processes, regulatory requirements, and industry standards. Knowledge of CDISC standards, 21 CFR Part 11 requirements, and ICH Good Clinical Practice (GCP) guidelines. Strong analytical thinking, problem-solving abilities, and attention to detail. Excellent communication, teamwork, and stakeholder management skills. Ability to manage multiple priorities in a fast-paced clinical development environment. Demonstrated initiative, adaptability, and commitment to continuous learning. Benefits: Competitive annual salary range of $125,500 - $165,500 depending on experience, skills, education, certifications, and location. Opportunity to participate in annual bonus programs and equity opportunities. Comprehensive healthcare benefits including medical, dental, and vision coverage. 401(k) retirement plan with additional financial wellness resources. Flexible Spending Account (FSA) and Health Savings Account (HSA) options. Life insurance coverage. Paid time off and wellness benefits. Remote work flexibility available. Opportunity to contribute to innovative clinical research programs focused on improving patient outcomes worldwide.

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