**Job title** : _Data_ **_Validation QC Reviewer_** + _Hiring Manager:_ **_Project Lead-ESR & Grants_** + _Location:_ **_Hyderabad_** + _% of travel expected:_ **_Travel required as per business need_** + _Job type:_ **_Permanent and Full time_** About the job **Our Team:** _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 Data Validation 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** : 3+ 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. Pursue progress, discover extraordinary. Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)