Clinical Data Associate

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

I'm partnering with an innovative biotechnology company seeking a Clinical Data Associate (CDA) to support clinical studies through data management activities, data review, discrepancy management, database quality control, and vendor data reconciliation. This is an excellent opportunity for someone with clinical data management experience who enjoys working in a collaborative, fast-paced clinical development environment.

Requirements

• Associate's degree or higher
• 2+ years of clinical data management experience within a biotech, pharmaceutical, or CRO environment
• Hands-on experience with Electronic Data Capture (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

• Experience with Medidata Rave
• Experience supporting multiple clinical studies simultaneously
• Strong understanding of GCP and clinical data management best practices