Senior Clinical Data Reviewer

Clinnect; United States; On-site; USD 65,000 - 85,000; Full time

Job summary

A leading company in the pharmaceutical sector is looking for a Clinical Data Specialist. This role ensures compliance and accuracy of clinical trial data, involving oversight of data management activities, collaboration with clinical teams, and leveraging EDC tools. Candidates should hold a Bachelor’s degree and possess over 5 years of experience in data review and knowledge of regulatory standards.

Qualifications

• 5+ years of experience in data review (pharma/biotech/CRO).

Responsibilities

• Oversee data management activities from start-up through database lock.
• Develop eCRFs/EDC tools and support User Acceptance Testing.
• Review and clean data, resolve discrepancies, and maintain essential data documents.
• Conduct SAE reconciliation and manage third-party data integration.
• Collaborate with cross-functional teams to address data issues and maintain documentation.

Skills

Data review

Proficiency with EDC systems

Good Documentation Practices

Knowledge of ICH-GCP

Strong experience using Excel

Education

Bachelor’s degree in a scientific field

Job description

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Ensures the accuracy and compliance of clinical trial data, working closely with clinical teams to support data quality and integrity.

Key Responsibilities:

• Oversee data management activities from start-up through database lock.
• Develop eCRFs/EDC tools and support User Acceptance Testing.
• Review and clean data, resolve discrepancies, and maintain essential data documents.
• Conduct SAE reconciliation and manage third-party data integration.
• Collaborate with cross-functional teams to address data issues and maintain documentation.

Qualifications:

• Bachelor’s degree in a scientific field.
• 5+ years of experience in data review (pharma/biotech/CRO).
• Proficiency with EDC systems and Good Documentation Practices.
• Knowledge of ICH-GCP and FDA regulations.
• Strong experience using Excel.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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