Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool.
Main responsibilities:
Sanofi is seeking a meticulous and detail-oriented Clinical Data QC Reviewer to join our team. The successful candidate will be responsible for ensuring the accuracy and quality of clinical data through rigorous quality control and validation processes.
Key Responsibilities:
- Quality Control Review: Perform quality control review of deliverables as defined in the Quality Control Plan (QCP).
- Data Validation: Conduct data validation activities on registry clinical data to ensure accuracy and completeness.
- System and Data Collection: Understand system and data collection processes, including electronic Case Report Forms (eCRFs) in the Medidata RAVE (EDC) application.
- Data Review: Review data listings produced in SAS, ad-hoc reporting, and scanned reports for consistency and accuracy.
- User Acceptance Testing (UAT): Perform UAT for CRF changes and system updates, document findings, and ensure issues are resolved.
- Issue Log Management: Update the Issue Log, including input of data issues and documentation of issue resolution.
- Test Case Completion: Complete test cases per client training requirements to ensure data integrity.
· People: (1) Seek alignment with internal stakeholders, and appropriate prioritization of Registry study data management activities, and compliance with approved processes; (2) Support team initiatives and objectives, identify and recommend process improvements and initiatives, and participate in company initiatives with the primary objective of adding value to the business
· Performance: (1) Maintain project database and conduct routine critical analyses of registry study data management objectives and deliverables to proactively identify and communicate potential risks and possible efficiencies to the stakeholders and ensuring compliance; (2) Track relevant data management key performance indicators (KPIs); (3) Ensure operational excellence and compliance readiness.
- Process: (1) Perform quality control review of deliverables as defined in the Quality Control Plan (QCP). (2) Conduct data validation activities on registry clinical data to ensure accuracy and completeness. (3) Understand system and data collection processes, including electronic Case Report Forms (eCRFs) in the Medidata RAVE (EDC) application. (4) Review data listings produced in SAS, ad-hoc reporting, and scanned reports for consistency and accuracy. (5) Perform UAT for CRF changes and system updates, document findings, and ensure issues are resolved. (6) Update the Issue Log, including input of data issues and documentation of issue resolution. (7) Complete test cases per client training requirements to ensure data integrity.
· Stakeholder: (1) Commit to Customers – Understand, meet, and excel internal and external customer expectations to create positive impact through the evolution of the Registry Data management function. (2) Cooperate Transversally – Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact Registry study data management efficiency and execution.
About you
· Experience: 8+ years of experience with Medidata RAVE (EDC) application or other EDC systems. Strong attention to detail and analytical skills. Excellent communication and documentation skills. Experience in quality control, quality assurance, or data validation within the clinical research or pharmaceutical industry. 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. Excellent organizational and project management skills, and ability to meet deadlines and stakeholder management.
- Technical skills: Knowledge of Clinical Trial and/or real world evidence (RWE) data management, Ability to troubleshoot data issues and implement corrective actions. Proficiency in data management and analysis tools (e.g., SQL, SAS, R, Python). Understanding of validation protocols, standard operating procedures (SOPs), and regulatory requirements. Ability to identify and correct errors in clinical data sets.
- Education: Degree in a scientific discipline or a related Life science degree with substantial experiences with data management of clinical trials. 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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