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Data Validation Qc Reviewer

3+ years
Not Disclosed
10 Feb. 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

**Job Title**: Data Validation QC Reviewer  
**Location**: Hyderabad, India  
**Job Type**: Permanent, Full-time  
**Posted On**: January 31, 2025  
**Closing On**: February 28, 2025  

**About the Role**  
Sanofi's Business Operations team in Hyderabad is seeking a meticulous and detail-oriented Data Validation QC Reviewer. The role focuses on ensuring the accuracy and quality of clinical data through quality control and validation processes. The ideal candidate will be responsible for reviewing clinical data, conducting validation activities, and ensuring adherence to quality control plans (QCP).

**Key Responsibilities**  
- Perform quality control review of deliverables based on the Quality Control Plan (QCP).
- Conduct data validation activities on clinical data, ensuring accuracy and completeness.
- Review data listings produced in SAS and ad-hoc reporting.
- Perform User Acceptance Testing (UAT) for CRF changes and system updates, documenting findings and ensuring issue resolution.
- Maintain project database and conduct routine analysis of data management objectives.
- Track data management key performance indicators (KPIs).
- Collaborate with internal stakeholders and ensure compliance with approved processes.

**Experience and Skills**  
- 3+ years of experience with Medidata RAVE (EDC) or other EDC systems.
- Strong attention to detail and excellent analytical skills.
- Experience in quality control, data validation, and clinical data management.
- Familiarity with regulatory guidelines (FDA, EMA, ICH) and Good Clinical Practice (GCP) standards.
- Proficiency in data management and analysis tools such as SQL, SAS, R, or Python.
- Excellent written and oral communication skills.

**Educational Qualifications**  
- Degree in a scientific discipline or related Life Science field with substantial experience in clinical trials data management.

**Soft Skills**  
- Strong organizational skills, ability to meet deadlines, and effective stakeholder management.

**Technical Skills**  
- Ability to troubleshoot data issues and implement corrective actions.
- Knowledge of standard operating procedures (SOPs) and regulatory requirements.

**Why Sanofi?**  
At Sanofi, we embrace diversity and encourage innovation. We believe progress doesn't happen without people—people from diverse backgrounds, united by a desire to make miracles happen. Join us to pursue progress and discover extraordinary together.

**Apply Now** and be a part of something extraordinary!