Senior Clinical Data Analyst
- Posted 20 hours ago
- Be among the first 10 applicants
Job Description
Job Summary
The Clinical Data Management Associate will support the Data Management Lead (DML) in the planning, setup, execution, monitoring, and closeout of clinical studies. The role is responsible for database build activities, data review, vendor oversight, study documentation, quality management, and ensuring high-quality clinical data delivery in compliance with regulatory requirements, SOPs, and study timelines.
Key Skills & Experience
The Clinical Data Management Associate will support the Data Management Lead (DML) in the planning, setup, execution, monitoring, and closeout of clinical studies. The role is responsible for database build activities, data review, vendor oversight, study documentation, quality management, and ensuring high-quality clinical data delivery in compliance with regulatory requirements, SOPs, and study timelines.
Key Skills & Experience
- 8+ years of End-to-end Clinical Data Management experience from protocol review, CRF/eCRF design through database lock.
- Strong experience in EDC systems: Medidata RAVE and Oracle Clinical.
- Expertise in Data Review, Query Management, Query Trend Analysis, Protocol Deviation Review, and Data Quality oversight.
- Experience authoring and reviewing DQMP, DVP, DRP, PDRP, eCRF Completion Guidelines, and related study documents.
- Knowledge of FDA/ICH-GCP guidelines, clinical drug development process, and regulatory submission requirements.
- Experience overseeing CRO/CDM vendors and managing study deliverables within timelines.
- Strong project management, metrics reporting, and stakeholder management skills.
- Experience supporting audits, inspections, and cross-functional study teams.
- Excellent communication, mentoring, and leadership abilities.
- Support DML in study planning, execution, and project management activities.
- Draft EDC build timelines and perform database/edit check specification activities.
- Conduct UAT/testing for database, coding, site payment, and safety integrations.
- Create and maintain study documents and ensure filing in eTMF per study requirements.
- Coordinate data review activities and vendor deliverables.
- Support Data Quality Review meetings and provide study metrics.
- Manage post-production, migration, and database lock activities.
- Ensure high-quality, timely study delivery in compliance with SOPs and regulatory requirements.
- Provide training and mentoring to junior Clinical Data Management staff.
More Info
Key Skills
Query Management
clinical drug development process
Data Quality oversight
eCRF Completion Guidelines
cross-functional study teams
EDC systems
audits inspections
Query Trend Analysis
DQMP
FDA ICH-GCP guidelines
Protocol Deviation Review
PDRP
regulatory submission requirements
End-to-end Clinical Data Management
Medidata RAVE
DVP
About Company