Senior Manager, Real World Evidence

🔥 6 minutes ago

🌐 United States, United Kingdom – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $151.2k - $226.8k / year

⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• Lead end-to-end operational planning, implementation, management, and closeout of global and regional observational studies • Drive execution of prospective observational cohorts, disease registries, pragmatic studies, retrospective chart reviews, and secondary real-world data linkage projects • Facilitate cross-functional study team meetings and align RWE, HEOR, Medical Affairs, Biostatistics, Data Analytics, Regulatory, and Legal/Privacy teams • Serve as primary escalation point for operational risks, data access hurdles, and timeline deviations • Manage study-level documentation, study master files, protocol versions, operational plans, data management plans, and archiving • Lead development and review of operational plans, protocol synopses, observational research protocols, statistical analysis plans, and feasibility assessments • Oversee informed consent templates, recruitment strategies, site selection, eCRF design, site contracting, data abstraction forms, database licensing, data transfer specifications, data linkage agreements, and variable mapping documents • Manage protocol amendments and IRB/Ethics Committee submission packages • Coordinate review and approval of final Study Reports and manuscripts • Oversee external service providers, including RWE CROs, data aggregators, academic research institutions, and chart abstraction vendors • Participate in vendor selection, RFP processes, SOW drafting, and contract negotiations • Track study timelines and budgets; analyze vendor invoices, milestones, and change orders • Monitor vendor deliverables and KPIs for data quality, regulatory compliance, and protocol adherence • Identify and manage operational and data-related risks • Ensure compliance with GPP, GCP where applicable, local/international regulations, HIPAA/GDPR, and internal SOPs • Act as operational lead and SME during audits, quality reviews, and regulatory inspections • Provide project status, milestone tracking, risk mitigation strategies, and budget updates to senior leadership • Lead cross-functional Study Execution Teams and matrix teams • Mentor and coach junior study managers, research associates, and project coordinators • Drive operational process improvements, template updates, and SOP refinements

🎯 Requirements

• 6+ years of research project management experience in biotechnology, pharmaceuticals, or contract research organizations (CROs) • Minimum 3+ years specifically focused on leading observational studies, including both prospective designs and retrospective designs • Deep operational understanding of real-world data sources, including Flatiron, Optum, IQVIA, Datavant linkages, claims databases, and registries • Knowledge of non-interventional study governance, ethics committee/IRB waiver processes, informed consent for observational cohorts, and health data privacy regulations (HIPAA, GDPR) • Familiarity with Good Pharmacoepidemiology Practice (GPP) and ISPOR/ISPE guidelines for RWE execution • Proven track record of managing multi-site prospective observational studies and complex retrospective secondary data projects • Strong contract, budget, and vendor oversight experience with RWE vendors, CROs, and data platform providers • Proficiency in electronic systems utilized in observational research, such as eTMF, CTMS, EDC, and data governance platforms • Excellent organizational, time-management, and analytical skills • Outstanding cross-functional leadership, stakeholder management, and written/verbal communication skills • Ability to work effectively in matrixed environments across scientific, analytical, regulatory, and business units • Required: Bachelor’s degree in Life Sciences, Epidemiology, Public Health, Health Informatics, Healthcare Administration, or a related field

🏖️ Benefits

• Discretionary annual cash bonus or incentive compensation • Discretionary equity grants • Medical insurance • Dental insurance • Vision insurance • 401k retirement savings plan • Flexible paid vacation

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