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Senior Program Manager, Clinical Data Review
Location
United States
Posted
84 days ago
Salary
0
Seniority
Senior
Job Description
Senior Program Manager, Clinical Data Review
ICON plc
• 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. • Contribute 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.
Job Requirements
- 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.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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