Senior Program Manager, Clinical Data Review

Senior Program Manager, Clinical Data Review

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

What You Will Be Doing:

• Lead clinical data review activities across assigned clinical studies or programs, ensuring medically meaningful interpretation of emerging efficacy and safety data.

• Perform comprehensive review of clinical data listings, patient profiles, and integrated datasets to identify clinically relevant trends, safety signals, protocol deviations, and potential data inconsistencies.

• Provide clinical oversight of data review outputs including safety data, laboratory results, vital signs, exposure, prohibited medications, efficacy endpoints, and adverse events.

• Identify potential safety signals or medically significant trends and collaborate with Pharmacovigilance, Clinical Science, and Medical Monitor teams to ensure appropriate evaluation and escalation.

• Serve as a clinical subject matter expert (SME) supporting ongoing data review during key study milestones including interim analyses, data cuts, regulatory submissions, and database locks.

• Collaborate cross-functionally with Clinical Science, Medical Monitors, Clinical Operations, Biostatistics, Pharmacovigilance, Data Management, and Programming to resolve clinically relevant data issues.

• Contributes to the development and implementation of standardized clinical data review frameworks, including review plans, flagging matrices, and escalation pathways.

• Support risk-based data review strategies aligned with RBQM principles to focus on clinically meaningful signals and patient safety indicators.

• Ensure inspection-ready documentation of clinical data review activities, decisions, and escalation pathways.

• Provide clinical input into data review listings, dashboards, and visualization tools to ensure outputs support meaningful medical interpretation.

• Lead or support cross-study and program-level data reviews, identifying trends across subjects, sites, and treatment arms.

• Participate in safety review meetings, clinical review forums, and data review working groups to communicate emerging findings.

• Maintain strong understanding of GCP, ICH guidelines, and regulatory expectations related to clinical data review and patient safety monitoring.

Your Profile:

• Bachelor’s degree required; Advanced degree (MS, PharmD, PhD, or MD) preferred in Life Sciences, Nursing, Pharmacy, or a related field

• Minimum of 5 years of experience in the pharmaceutical, biotechnology, or CRO industry, with a focus on clinical data review, clinical operations, or clinical science

• Demonstrated experience reviewing and interpreting clinical trial data (e.g., listings, patient profiles, safety and efficacy data) to identify trends, inconsistencies, and potential safety signals

• Strong understanding of clinical trial processes, including study conduct, data flow, and key milestones (interim analyses, database lock, regulatory submissions)

• Experience collaborating cross-functionally with teams such as Clinical Science, Medical Monitoring, Pharmacovigilance, Data Management, and Biostatistics

• Knowledge of GCP, ICH guidelines, and regulatory requirements related to clinical trials and patient safety monitoring

• Familiarity with risk-based monitoring (RBM/RBQM) principles and data review strategies preferred

• Medical coding experience (e.g., MedDRA, WHO Drug) preferred

• Ability to interpret complex clinical data and translate findings into clear, actionable insights for cross-functional stakeholders

• Strong analytical skills with high attention to detail and the ability to identify clinically meaningful patterns in large datasets

• Experience contributing to or developing data review plans, listings, dashboards, or visualization tools is preferred

• Excellent communication skills, with the ability to present clinical data findings in meetings, safety reviews, and cross-functional forums

• Proven ability to manage multiple studies or priorities in a fast-paced environment while maintaining quality and timelines

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits.