Data Validation Team Member

3+ years

Not Disclosed

Hyderabad

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

Here is the rewritten job description with a unique slug:

Data Validation Team Member | Hyderabad, India | Permanent | Sanofi

Posted on: Jan. 29, 2025
Closing on: Mar. 27, 2025

About the Job:

Sanofi is looking for a Data Validation Team Member to join their Business Operations team in Hyderabad. This permanent, full-time role focuses on ensuring the accuracy and quality of clinical data through comprehensive validation and quality control processes. The role will work closely with multiple internal stakeholders to uphold data integrity, providing reliable insights and ensuring compliance with regulatory standards.

Key Responsibilities:

Data Collection & Verification:
- Understand data collection processes, including eCRFs in the Medidata RAVE (EDC) application.
- Verify data consistency and identify discrepancies for resolution.
Query & Issue Management:
- Raise and manage queries to resolve data issues efficiently.
- Update issue logs with data-related resolutions.
Testing & Metrics:
- Perform User Acceptance Testing (UAT) for CRF changes and system updates.
- Create and track metrics related to form entry and query management.
Data Review & Quality Control:
- Review data listings, ad-hoc reporting, and scanned reports for accuracy.
- Ensure quality control of all in-scope activities.
Reconciliation & Documentation:
- Perform data reconciliation to ensure data integrity.
- Draft project documents and provide input to Data Review Guidelines (DRG) and Quality Management & Control Plan.
Stakeholder Alignment & Training:
- Align with internal stakeholders to prioritize study data management activities.
- Facilitate training for new team members and create test cases.

About You:

Experience:
- 3+ years of experience with Medidata RAVE (EDC) application and SAS.
- Previous experience in the pharmaceutical or clinical research industry with strong attention to detail and analytical skills.
Soft Skills:
- Excellent organizational, communication, and project management skills.
- Ability to work independently and as part of a team while maintaining confidentiality.
Technical Skills:
- Proficiency in data management tools such as SQL, SAS, R, and Python.
- Knowledge of data cleaning, validation techniques, and regulatory guidelines (FDA, EMA).
Education:
- Degree in a scientific or related life sciences discipline.
- Experience in clinical trial data management is highly valued.
Languages:
- High proficiency in written and spoken English.

What We Offer:

Join Sanofi to contribute to groundbreaking advancements in medicine. You’ll be part of a diverse team, united by a shared commitment to making a difference in global healthcare.

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Data Validation Team Member

Job Description

Data Validation Team Member | Hyderabad, India | Permanent | Sanofi

About the Job:

Key Responsibilities:

About You:

What We Offer:

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