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 supportparticipant-levelclinical data review data cleaning and operational oversight across clinical development programs.
Engage with cross-functional teams to understand thestudyreporting requirements and translate them to reporting specifications ensuring outputs areof high-qualityaccuratetimelyand aligned with data management and regulatory expectations.
Ensurethattheclinicaldata reportingsolutionsprovideactionable insights to improve clinicaldataoversightfacilitateefficientdata cleaning and reviewmonitoroperational performanceenableimproved visibility and decision-making.
Partner with clinical data management and technology partners to ensure that the reporting solutions effectivelyutilizethe Scientific Data Lake EDC system and external data streams.
Provide subject matterexpertiseon reporting capabilities data structures and data review workflows.
Identifyopportunities 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 andaudit ready.
Deliver operational insights toidentifyrisks bottlenecks and opportunities to drive process improvements and optimization initiatives.
Ensure alldatareportingworkflowsand outputsarevalidated documentedandcompliantwith 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 membersengagedinreporting data review or data integration activities.
Stay updated on emerging technologies and tools in datareporting methodologies and approachesto enhancebusinesscapabilities.
Drive the adoption of innovativereportingsolutions to improve the efficiency and scalability of clinicaldatareportingsolutions.
Foster a culture of collaboration innovation and continuous improvement within theClinical Data Operationsteam.
Requirements:
Bachelors orMasters degree in Data Science Computer Science Life Sciences ora 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.
ProficiencyinEDC systems (e.g. Medidata RAVE)andanalyticsreportinganddata visualization tools such asJReviewelluminateSAS RTableau Power BI or Spotfire.
Experience withrisk-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.GCPGDPR HIPAA).
Experience with data lakes data pipelines data integration automationreportingand analyticsin 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 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 Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons 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 Companys 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)
Required Experience:
Manager
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