Manager, Clinical Data Reporting

The Mgr, Clinical Data Reporting will lead the development, delivery, and maintenance of high-quality clinical data reporting solutions, essential for efficient data review, operational oversight, and the generation of reports and listings across clinical development programs. This role involves transforming complex clinical and operational data into clear, reliable, consistent, and actionable reports by leveraging established data management processes, enterprise data sources, and standardized reporting frameworks. Responsibilities include creating participant-level data review listings, exception reports, external data reconciliation outputs, and reports to monitor and improve operational oversight and performance. The role requires strong expertise in clinical data programming, clinical data management processes and systems, external data reconciliation, and reporting methodologies. The ideal candidate will work closely with cross-functional teams to ensure reporting needs are met across studies, while driving consistency, accuracy, and continuous improvement in reporting practices.

Responsibilities:

• Lead the design, build, and maintenance of standardized clinical data reports and listings that support participant-level clinical data review, data cleaning, and operational oversight across clinical development programs.

• Engage with cross-functional teams to understand the study reporting requirements and translate them to reporting specifications, ensuring outputs are of high-quality, accurate, timely, and aligned with data management and regulatory expectations.

• Ensure that the clinical data reporting solutions provide actionable insights to improve clinical data oversight, facilitate efficient data cleaning and review, monitor operational performance, enable improved visibility and decision-making.

• Partner with clinical data management and technology partners to ensure that the reporting solutions effectively utilize the Scientific Data Lake, EDC system, and external data streams.

• Provide subject matter expertise on reporting capabilities, data structures, and data review workflows.

• Identify opportunities to streamline reporting processes, automate manual tasks, and improve reporting efficiency and consistency.

• Monitor data flows and troubleshoot issues related to accuracy, data completeness, and refresh cycles.

• Support inspection readiness by ensuring reporting outputs and documentation are complete, traceable, and audit ready.

• Deliver operational insights to identify risks, bottlenecks, and opportunities to drive process improvements and optimization initiatives.

• Ensure all data reporting workflows and outputs are validated, documented, and compliant with GCP, ICH, GDPR, SOPs, and regulatory expectations.

• Support training efforts related to reporting tools, standards, and processes.

• Contribute to the development and enhancement of reporting frameworks, documentation, and best practices.

• Provide leadership and guidance to junior team members engaged in reporting, data review, or data integration activities.

• Stay updated on emerging technologies and tools in data reporting methodologies and approaches to enhance business capabilities.

• Drive the adoption of innovative reporting solutions to improve the efficiency and scalability of clinical data reporting solutions.

• Foster a culture of collaboration, innovation, and continuous improvement within the Clinical Data Operations team.

Requirements:

• Bachelor’s or Master’s degree in Data Science, Computer Science, Life Sciences, or a related field.

• 7+ 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 JReview, elluminate, SAS, R, 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 have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)