Clinical Data Associate: Drive Accurate, Compliant Trials

Meet Life Sciences Ltd.; Bridgewater (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Meet Life Sciences Ltd. seeks a Clinical Data Associate (CDA) to support clinical studies through data management activities, data review, discrepancy management, database quality control, and vendor data reconciliation in a collaborative, fast-paced development environment.

The role requires an associate degree or higher and 2+ years of CDA experience in biotech/pharma/CRO, hands-on EDC experience with Medidata Rave preferred, and strong organizational, communication, and problem-solving skills

Qualifications

• Associate's degree or higher is required.
• 2+ years of clinical data management experience in biotech/pharma/CRO.
• Hands-on experience with EDC systems.
• Experience with Medidata Rave preferred.
• Strong organizational, communication, and problem-solving skills.
• Experience working in cross-functional clinical study teams.

Responsibilities

• Support maintenance and updates of Data Management Plans, Data Validation Plans, Data Review Plans, and CRF Completion Guidelines
• Review and verify external vendor data according to study specifications
• Generate, review, and track study data metrics and reports
• Participate in ongoing data review activities
• Review, manage, and resolve data discrepancies within EDC systems
• Perform external data reconciliations, including Serious Adverse Event (SAE) reconciliation
• Conduct database quality control activities and support database review processes
• Track data issues and communicate trends to study teams for follow-up
• Ensure compliance with company procedures, GCP guidelines, and regulatory requirements
• Maintain study documentation and support Trial Master File (TMF) activities
• Preferred: Medidata Rave experience; experience supporting multiple clinical studies; strong understanding of GCP and CDM best practices

Skills

EDC systems

Medidata Rave

Cross-functional teams

Communication skills

Education

Associate's degree or higher

Tools

Medidata Rave

EDC systems

Job description

Meet Life Sciences Ltd. seeks a Clinical Data Associate (CDA) to support clinical studies through data management activities, data review, discrepancy management, database quality control, and vendor data reconciliation in a collaborative, fast-paced development environment.

The role requires an associate degree or higher and 2+ years of CDA experience in biotech/pharma/CRO, hands-on EDC experience with Medidata Rave preferred, and strong organizational, communication, and problem-solving skills