Senior Clinical Data Analyst: Drive Data Quality & Trials

Influx Infosys

United States

Remote

USD 90,000 - 140,000

Full time

29 hours ago
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Job summary

Influx Infosys in the United States is seeking a Senior Clinical Data Coordinator / Clinical Data Analyst with extensive experience in clinical data management and research environments. You will coordinate data activities, review trial data, and support database development across cross-functional teams.

The role emphasizes data quality, discrepancy resolution, EDC oversight, data reconciliation across sources, and preparation for analysis and database lock.

Qualifications

  • 5+ years of experience in Clinical Data Management, Clinical Data Coordination, or related clinical research function.
  • Strong understanding of clinical trial data management processes.
  • Experience with EDC systems such as Medidata Rave, Oracle Clinical, or Veeva.
  • Experience with data review, discrepancy management, and query resolution.
  • Knowledge of CDISC standards (CDASH/SDTM) is preferred.
  • Experience across cross-functional clinical teams.
  • Excellent communication and attention to detail.

Responsibilities

  • Coordinate and support clinical data management activities across clinical studies.
  • Review clinical trial data for completeness, accuracy, consistency, and quality.
  • Perform ongoing data review and identify discrepancies, missing data, and data quality issues.
  • Generate, review, and track data queries and coordinate resolution with clinical sites and study teams.
  • Support clinical database development, testing, validation, and maintenance.
  • Review electronic data capture (EDC) systems and clinical data collected from multiple sources.
  • Perform data reconciliation between EDC and external data sources such as laboratories, ECG, imaging, ePRO/eCOA, and safety systems.
  • Develop and maintain data review reports, data listings, and tracking reports.
  • Support User Acceptance Testing (UAT) and system validation activities.
  • Participate in database lock preparation and execution activities.
  • Assist with clinical data cleaning and ensure study data are ready for analysis and database lock.
  • Review and maintain clinical data management documentation, including Data Management Plans and data review specifications.
  • Work closely with Clinical Data Managers, CRAs, Clinical Operations, Biostatistics, Medical Affairs, and Statistical Programming teams.
  • Support study teams in resolving data-related issues and discrepancies.
  • Monitor study data and communicate trends, risks, and outstanding issues to project stakeholders.
  • Assist with development and maintenance of clinical data reports and dashboards.
  • Ensure clinical data activities follow applicable SOPs, protocols, regulatory requirements, and industry standards.
  • Participate in study team meetings and provide updates on data quality and data management activities.
  • Support inspection readiness and provide documentation during audits or regulatory inspections when required.
  • Maintain accurate documentation and tracking of clinical data activities throughout the study lifecycle.

Skills

Clinical Data Management
Data Review & Cleaning
Query Generation & Resolution
EDC Systems
Data Reconciliation
CDISC CDASH SDTM
SQL / SAS
Data Visualization
Regulatory & GxP
Communication & Collaboration

Education

Bachelor's degree in Life Sciences

Tools

Medidata Rave
Oracle Clinical
Veeva
SQL
SAS
Excel

Job description

Influx Infosys in the United States is seeking a Senior Clinical Data Coordinator / Clinical Data Analyst with extensive experience in clinical data management and research environments. You will coordinate data activities, review trial data, and support database development across cross-functional teams.

The role emphasizes data quality, discrepancy resolution, EDC oversight, data reconciliation across sources, and preparation for analysis and database lock.

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