About This Role
Working closely with the Principal Data Manager and cross-functional partners, you will help ensure clinical trial data is accurate, complete, reliable, and ready to support critical study milestones and regulatory submissions. This is an opportunity to take ownership of day-to-day data management activities across the clinical trial lifecycle, from study start-up and database development through data cleaning, database lock, and regulatory submission.
Responsibilities
- Manage day-to-day clinical data activities for assigned studies, ensuring alignment with study protocols, Data Management Plans, regulatory requirements, and company procedures
- Support the development and maintenance of clinical databases, electronic Case Report Forms (eCRFs), data management documentation, and related guidelines
- Perform data cleaning, query management, data validation, reconciliation, and quality control to ensure accurate, complete, and consistent clinical trial data
- Monitor data quality, outstanding queries, discrepancies, and study timelines, proactively communicating risks and escalating issues as needed
- Support database lock preparation and execution, including data cleaning, reconciliation, documentation review, and resolution of outstanding issues
- Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs, Clinical Affairs, clinical research sites, and external vendors to support timely data collection, review, and delivery
- Support electronic data capture (EDC) system activities, including user acceptance testing, troubleshooting, and coordination with system vendors
- Prepare and review clinical data listings, reports, data transfers, and other deliverables supporting clinical study reports and regulatory submissions
- Maintain accurate, traceable, audit-ready documentation and support internal audits, regulatory inspections, and quality reviews
- Support compliance with applicable FDA regulations, 21 CFR Part 11, ICH-GCP, ISO 14155, EU MDR, and relevant clinical data standards
- Identify opportunities to improve data management processes, strengthen data quality, and promote consistency across clinical studies
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Clinical Research, Statistics, Computer Science, or a related technical field
- 3–6 years of experience in clinical data management, preferably within the medical device industry
- Experience supporting clinical trials across the data management lifecycle, including database development, data cleaning, query management, and database lock
- Working proficiency with Electronic Data Capture (EDC) systems, such as Medidata Rave or CatchTrials, and familiarity with CRF/eCRF design
- Knowledge of clinical data validation, reconciliation, quality control, and data integrity requirements