Senior Manager, Real World Evidence

Jazz Pharmaceuticals

. Lead end-to-end operational planning, implementation, management, and closeout of global and regional observational studies .

Posted 11/3/2026full-timeRemote • Pennsylvania • United States, United KingdomSenior💰 $151,200 - $226,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading observational studies, managing cross-functional teams, and ensuring compliance with regulatory standards. Proficient in operational planning, risk management, and vendor oversight within the biotechnology and pharmaceutical sectors.

Highest-signal resume keywords

Research Project ManagementObservational Study LeadershipReal-World Data ExpertiseRegulatory Compliance KnowledgeCross-Functional Team Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Operational PlanningData ManagementStatistical AnalysisProtocol DevelopmentRisk MitigationBudget ManagementVendor OversightStudy Documentation ManagementFeasibility AssessmentData Quality Monitoring

Soft Skills

Organizational SkillsTime ManagementAnalytical SkillsStakeholder ManagementCommunication Skills

Tools & Technologies

ETMFCTMSEDCData Governance PlatformsFlatironOptumIQVIADatavantClaims DatabasesRegistries

Industry Keywords

Good Pharmacoepidemiology PracticeHealth Data Privacy RegulationsIRB Waiver ProcessesNon-Interventional Study GovernanceBiotechnologyPharmaceuticalsContract Research Organizations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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