Clinical Data Reporting Specialist

Job description

Job Title: Clinical Data Reporting Specialist Job Level: Specialist Department: Data Management Reports To: Sr.Director, India/Director, US/Associate Director, USData Management Operations Location:Hyd, India FLSA Status:Exempt The Specialist, Clinical Data Reporting supports the creation and delivery of clinical data reporting outputs used for data review and study oversight. This role focuses on hands‑on programming tasks, working with clinical and operational datasets to produce accurate and consistent reports following established processes and standards. The Specialist collaborates with data management and cross‑functional teams to understand reporting needs and ensure timely delivery of study‑level outputs. The key responsibilities include programming participant‑level data review listings to support routine data cleaning and medical review, generating exception reports to identify data discrepancies, and assisting with external data reconciliation by producing comparison outputs between EDC and external data sources. The role also involves preparing operational reports that summarize study progress and data flow metrics, following established reporting standards and templates, and performing validation checks to ensure accuracy and consistency of all outputs. Additionally, the Specialist works closely with cross‑functional partners to clarify reporting requirements, deliver outputs on schedule, and help maintain reporting tools and documentation.       JOB DUTIES:  List essential (6-10) to be performed.  These are the most critical responsibilities. ·       Support the programming and maintenance of standardized clinical data reports and listings used for participant‑level data review, data cleaning, and operational oversight. ·       Assist in translating study reporting requirements into technical reporting specifications and implement reporting outputs using established frameworks and data standards. ·       Program and validate data review listings, exception reports, reconciliation outputs, and operational performance reports using clinical and operational data sources. ·       Ensure reporting outputs are accurate, consistent, and delivered in alignment with data management and quality expectations. ·       Work with clinical data management and technology partners to ensure reporting solutions appropriately use available data sources such as the Scientific Data Lake, EDC systems, and external data streams. ·       Monitor routine data refreshes and help troubleshoot issues related to data accuracy, completeness, and integration. ·       Contribute to efforts that improve reporting efficiency by supporting automation and workflow streamlining activities. ·       Maintain reporting documentation, specifications, and outputs to support inspection readiness and audit requirements. ·       Provide reporting outputs that help highlight potential risks, delays, or data quality issues within studies. ·       Follow GCP, ICH, GDPR, SOPs, and internal quality standards in all reporting activities. ·       Assist in monitoring data pipelines and resolving basic issues related to data refresh cycles and completeness. ·       Support team members by sharing knowledge of reporting tools, standards, and processes when needed. ·       Stay informed about reporting tools and methodologies to support ongoing skill development. ·       Participate in team discussions that promote collaboration, knowledge sharing, and continuous improvement within Clinical Data Operations.   JOB REQUIREMENTS: List knowledge, skills, and abilities required to perform the job.   List any preferred job requirements as well.   ·       Bachelor’s or Master’s degree in Data Science, Computer Science, Life Sciences, or a related field. ·       2+ years of experience in clinical data, data visualization, or related disciplines, with a strong background in creating interactive reporting solutions, KPIs, and metrics to support clinical trial oversight. ·       Proficiency in EDC systems (e.g., Medidata RAVE) and analytics, reporting and data visualization tools such as SAS, R, Python, JReview, elluminate, , Tableau, Power BI, or Spotfire. ·       Experience with risk-based data review concepts, data quality standards, and strong understanding of data lifecycle management in a regulated environment. ·       Strong understanding of clinical trial processes, clinical data standards (e.g., CDISC), and regulatory requirements (e.g., GCP, GDPR, HIPAA). ·       Experience with data lakes, data pipelines, data integration, automation, reporting and analytics in a clinical research environment. ·       Excellent communication and stakeholder management skills. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all  qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or paren