Senior Manager, Real World Evidence

Jazz Pharmaceuticals • Philadelphia, PA

21h • Remote

About The Position

The Study Manager leads the operational planning, execution, management, and closeout of global and regional non-interventional observational research projects, including prospective studies such as patient registries and cohorts, and retrospective studies such as chart reviews, EHR analyses, claims database studies, and secondary data projects. The role ensures operational excellence, cross-functional alignment, vendor oversight, budget management, and timely delivery of high-quality Real-World Evidence (RWE) supporting clinical development, medical affairs, regulatory submissions, and value strategies.

The Study Project Manager serves as a subject matter expert in observational study execution, Good Pharmacoepidemiology Practice (GPP), data privacy compliance, and cross-functional study team leadership. The role leads study teams, oversees study documentation and external providers, manages operational risks and budgets, supports governance and compliance activities, and mentors junior colleagues. The position requires a bachelor’s degree in a relevant field; an advanced degree is preferred.

Requirements

• At least 6 years of research project management experience in biotechnology, pharmaceuticals, or CROs.
• At least 3 years leading observational studies, including both prospective designs such as registries or cohorts and retrospective designs such as EHR/claims database studies, chart reviews, or secondary data analyses.
• Deep operational understanding of real-world data sources, such as 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 including HIPAA and GDPR.
• Familiarity with GPP and ISPOR/ISPE guidelines for RWE execution.
• Demonstrated experience 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 with electronic systems used in observational research, such as eTMF, CTMS, EDC, and data governance platforms.
• Excellent organizational, time-management, and analytical skills.
• Strong cross-functional leadership, stakeholder management, and written and verbal communication skills.
• Ability to work effectively in matrixed environments across scientific, analytical, regulatory, and business units.
• Bachelor’s degree in Life Sciences, Epidemiology, Public Health, Health Informatics, Healthcare Administration, or a related field.

Nice To Haves

• Master’s or Ph.D. in Epidemiology, Public Health (MPH), Health Economics, or Life Sciences.

Responsibilities

• Lead end-to-end operational planning, implementation, management, and closeout of global and regional observational studies, including prospective and retrospective designs.
• Drive operational execution of observational cohorts, disease registries, pragmatic studies, retrospective chart reviews, and secondary real-world data linkage projects.
• Facilitate cross-functional Study Execution Team meetings and align RWE, HEOR, Medical Affairs, Biostatistics, Data Analytics, Regulatory, and Legal/Privacy stakeholders.
• Serve as the primary escalation point for operational risks, data access hurdles, and timeline deviations, and drive resolution.
• Manage study documentation, including study master files, protocol versions, operational plans, data management plans, and compliant archiving.
• Lead cross-functional development and review of operational plans, protocol synopses, observational research protocols, statistical analysis plans, and feasibility assessments.
• For prospective studies, oversee informed consent form templates, patient recruitment strategies, site selection, eCRF design, and site contracting.
• For retrospective studies, oversee data abstraction forms, database licensing, data transfer specifications, data linkage agreements, and variable mapping documents.
• Manage protocol amendments and IRB/Ethics Committee submission packages, including support for waiver applications for retrospective chart extraction or secondary data use.
• Coordinate review and approval of final study reports and manuscripts with publication and scientific communications teams.
• Oversee the operational performance of external service providers, including RWE CROs, data aggregators, academic research institutions, and chart abstraction vendors.
• Participate in vendor selection, RFP processes, scope of work drafting, and contract negotiations.
• Manage study timelines and budgets; analyze vendor invoices, milestones, and change orders.
• Monitor vendor deliverables and KPIs to ensure data quality, regulatory compliance, and protocol adherence.
• Identify, assess, and proactively manage operational and data-related risks affecting study quality, privacy, and timelines.
• Ensure observational research complies with GPP, applicable GCP, local and international regulations, HIPAA/GDPR privacy rules, and internal SOPs.
• Act as operational lead and subject matter expert during internal audits, quality reviews, and regulatory inspections related to observational data generation.
• Support program governance by providing project status, milestone tracking, risk mitigation strategies, and budget updates to senior leadership.
• Lead cross-functional Study Execution Teams and matrix teams to promote performance and accountability.
• Mentor and coach junior study managers, research associates, and project coordinators.
• Drive operational process improvements, template updates, and SOP refinements within the RWE/Evidence Operations organization.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement savings plan
• Flexible paid vacation
• Potential eligibility for a discretionary annual cash bonus or incentive compensation, depending on the role
• Potential eligibility for discretionary equity grants

What This Job Offers

• Job Type: Full-time
• Career Level: Senior