Job Title: Data Validation QC Reviewer
Location: Hyderabad, India
Job Type: Permanent
Date Posted: January 31, 2025
Application Deadline: February 28, 2025
About the Job:
Sanofi Business Operations (SBO) is seeking a meticulous and detail-oriented Data Validation QC Reviewer to join our dynamic team. As a key contributor, you will ensure the accuracy and quality of clinical data through rigorous quality control and validation processes, supporting our global mission to advance healthcare.
Main Responsibilities:
Quality Control & Data Validation:
Perform quality control review of deliverables as defined in the Quality Control Plan (QCP).
Conduct data validation activities on registry clinical data to ensure accuracy and completeness.
Review data listings produced in SAS, ad-hoc reporting, and scanned reports for consistency and accuracy.
System and Data Collection:
Understand system and data collection processes, including electronic Case Report Forms (eCRFs) in the Medidata RAVE (EDC) application.
Perform User Acceptance Testing (UAT) for CRF changes and system updates, document findings, and ensure issues are resolved.
Issue Management & Test Case Completion:
Update the Issue Log, including input of data issues and documentation of issue resolution.
Complete test cases per client training requirements to ensure data integrity.
Performance & Compliance:
Maintain project databases and conduct routine critical analyses of registry study data management objectives.
Track relevant data management key performance indicators (KPIs).
Ensure operational excellence and compliance readiness.
Stakeholder Engagement:
Commit to delivering high-quality results for internal and external customers.
Collaborate effectively with peers, stakeholders, and partners across the organization.
About You:
Experience:
3+ years of experience with Medidata RAVE (EDC) application or other EDC systems.
Strong attention to detail and analytical skills.
Hands-on experience with clinical data management and validation processes.
Familiarity with guidelines from regulatory bodies such as the FDA, EMA, and ICH.
Knowledge of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards.
Soft Skills:
Excellent written and oral communication skills.
Strong organizational and project management abilities.
Proven ability to manage deadlines and stakeholder expectations.
Technical Skills:
Proficiency in data management and analysis tools (e.g., SQL, SAS, R, Python).
Ability to troubleshoot data issues and implement corrective actions.
Understanding of validation protocols, standard operating procedures (SOPs), and regulatory requirements.
Education:
Degree in a scientific discipline or related life sciences field.
Efficiently managing multiple tasks and deadlines.
Meticulous in reviewing data to ensure accuracy and completeness.
Languages:
High proficiency in written and spoken English.
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