Be Part Of A High-Performing Team
Join a collaborative clinical data management team supporting the successful execution of clinical studies in a highly regulated life sciences environment. This role works closely with Data Management study leads and cross-functional clinical partners to maintain high-quality study data, resolve discrepancies, support database activities, and ensure data management processes remain compliant with Good Clinical Practice (GCP), internal procedures, and applicable regulatory requirements.
What’s In Store For You
This opportunity provides hands-on exposure across the clinical data management lifecycle, including EDC data review, external data reconciliation, database quality control, documentation, User Acceptance Testing (UAT), and study metrics. The Clinical Data Associate will work alongside experienced clinical and data management professionals while contributing directly to the quality and integrity of clinical study data.
How You Will Make An Impact
- Support Data Management study leads with day-to-day clinical data management activities across assigned studies.
- Assist with updates to key study documentation, including Data Management Plans, Data Validation Plans, Data Review Plans, and CRF Completion Guidelines.
- Perform data review within Electronic Data Capture systems and identify discrepancies requiring investigation or clarification.
- Review, manage, close, or re-query discrepancies in accordance with study-specific guidelines.
- Monitor data quality trends and communicate relevant findings to clinical trial management partners.
- Verify external vendor test data against established specifications.
- Reconcile external data with the clinical study database, including Serious Adverse Event (SAE) reconciliation.
- Generate and review study outputs, listings, and database metrics.
- Participate in ongoing study data reviews and database quality-control activities.
- Track data management issues through resolution and maintain accurate study documentation.
- Support appropriate filing of Data Management documentation within the Trial Master File.
- Ensure activities consistently follow established Data Management procedures, GCP expectations, and applicable regulations.
Are You an Experienced Clinical Data Management Professional Ready to Make an Impact?
- Associate degree or higher is required.
- Approximately 2+ years of clinical data management experience within a biotechnology, pharmaceutical, or CRO environment is preferred.
- Hands-on experience working with Electronic Data Capture (EDC) systems is required.
- Experience with Medidata Rave is strongly preferred.
- Experience reviewing clinical data, managing discrepancies or queries, and supporting database quality activities.
- Familiarity with clinical data reconciliation, including external vendor data and SAE reconciliation.
- Understanding of clinical data management documentation and study-specific data review processes.
- Ability to work effectively within cross-functional clinical study teams.
- Strong written and verbal communication skills.
- Strong organizational skills with attention to detail and the ability to manage multiple study-related activities.
- Ability to consistently follow established processes and operate effectively within a regulated clinical research environment.
