Senior Manager, Real World Evidence

Jazz Pharmaceuticals; Philadelphia (Philadelphia County); On-site; USD 151,000 - 227,000; Full time

Job summary

Jazz Pharmaceuticals, Inc. is seeking a Study Manager to lead the operational planning, execution, and closure of non-interventional observational research projects, spanning prospective registries and retrospective chart reviews.

The role requires overseeing vendor oversight, budgets, and data privacy compliance while delivering high-quality Real-World Evidence to support clinical development and value strategies.

Qualifications

• 6+ years of research project management experience in biotechnology, pharmaceuticals, or CROs.
• Minimum 3+ years specifically leading observational studies (prospective and retrospective).
• Knowledge of real-world data sources and governance (HIPAA, GDPR).
• Familiarity with GPP and ISPOR/ISPE guidelines for RWE execution.

Responsibilities

• Lead end-to-end operational planning, execution, and closeout of global and regional observational studies (prospective and retrospective).
• Drive operational execution of prospective observational cohorts, registries, pragmatic studies, and secondary data linkages.
• Facilitate cross-functional study team meetings ensuring alignment among RWE leads, HEOR, Medical Affairs, Biostatistics, Data Analytics, Regulatory, and Legal/Privacy.
• Escalate and resolve study operational risks, data access hurdles, and timeline deviations.
• Maintain study master files, SOPs, and data management plans in compliance with SOPs.

Skills

Research project management

Observational study leadership

GPP / HIPAA knowledge

Education

Bachelor’s degree in Life Sciences

Advanced degree in Epidemiology / Public Health

Tools

eTMF

CTMS

EDC

Job description

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

The Study Manager leads the operational planning, execution, and closure of non-interventional, observational research projects—encompassing both prospective studies (e.g., patient registries, prospective cohort studies) and retrospective studies (e.g., retrospective chart reviews, electronic health record [EHR] analyses, claims database studies, and secondary data assets). This role ensures operational excellence, cross-functional alignment, vendor oversight, budget management, and timely delivery of high-quality Real-World Evidence (RWE) to support clinical development, medical affairs, regulatory submissions, and value strategies. The Study Project Manager serves as a Subject Matter Expert (SME) in observational study execution, Good Pharmacoepidemiology Practice (GPP), data privacy compliance, and cross-functional study team leadership.

Essential Functions

Study Leadership & Operational Oversight

• Lead the end-to-end operational planning, implementation, management, and closeout of global and regional observational studies across prospective and retrospective designs.
• Drive the operational execution of prospective observational cohorts, disease registries, pragmatic studies, retrospective chart reviews, and secondary real-world data (RWD) linkage projects.
• Facilitate and lead cross-functional study team meetings (e.g., Study Execution Teams), ensuring alignment among RWE leads, HEOR, Medical Affairs, Biostatistics, Data Analytics, Regulatory, and Legal/Privacy.
• Serve as the primary point of escalation for study operational risks, data access hurdles, and timeline deviations, driving proactive resolution.
• Manage study-level documentation, ensuring maintenance of study master files, master protocol versions, operational plans, data management plans, and archiving in compliance with company standard operating procedures (SOPs).

Study Planning, Protocol Development & Documentation

• Lead cross-functional development and review of study-specific operational plans, protocol synopses, observational research protocols, statistical analysis plans (SAPs), and feasibility assessments.
• For prospective observational studies: Oversee informed consent form (ICF) templates, patient recruitment strategies, site selection, electronic Case Report Form (eCRF) design, and site contracting.
• For retrospective studies: Oversee data abstraction form design, EHR/claims database licensing, data transfer specifications, data linkage agreements, and variable mapping documents.
• Manage protocol amendments and IRB/Ethics Committee submission packages, supporting waiver of authorization applications for retrospective chart extractions or secondary data usage.
• Coordinate the review and approval of final Study Reports (SRs) and manuscripts in collaboration with publication and scientific communications teams.

Vendor & External Data Provider Oversight

• Accountable for the operational management and performance oversight of external service providers, including specialized RWE contract research organizations (CROs), data aggregators, academic research institutions, and chart abstraction vendors.
• Participate in vendor selection, Request for Proposal (RFP) processes, scope of work (SOW) drafting, and contract negotiations.
• Manage and track trial timelines and study budgets in line with projected spend; critically analyze vendor financial invoicing, milestones, and change orders.
• Monitor vendor deliverables and Key Performance Indicators (KPIs) to ensure data quality, regulatory compliance, and protocol adherence.

Risk Management, Governance & Compliance

• Identify, assess, and proactively manage operational and data-related risks to safeguard study quality, data privacy, and delivery timelines.
• Ensure all observational research activities comply with Good Pharmacoepidemiology Practice (GPP), Good Clinical Practice (GCP, where applicable), relevant local/international regulations, HIPAA/GDPR privacy rules, and internal SOPs.
• Act as the study operational lead and SME during internal audits, quality reviews, and regulatory inspections related to observational data generation.
• Support program-level governance discussions by providing timely project status, milestone tracking, risk mitigation strategies, and budget updates to senior leadership.

Leadership & Team Collaboration

• Lead cross-functional Study Execution Teams and matrix teams to maintain high performance and accountability.
• Mentor and coach junior study managers, research associates, or project coordinators.
• Drive operational process improvements, template updates, and SOP refinements within the RWE / Evidence Operations organization.

Experience

Required Knowledge, Skills, and Abilities

• 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 (registries, prospective cohorts) and retrospective designs (EHR/claims databases, chart reviews, secondary data analyses).

Observational Methodology & Data Knowledge

• Deep operational understanding of real-world data sources (e.g., Flatiron, Optum, IQVIA, Datavant linkages, claims databases, 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.

Project & Vendor Management

• 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 (e.g., eTMF, CTMS, EDC, data governance platforms).

Communication & Leadership

• 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/Preferred Education And Licenses

• Required: Bachelor’s degree in Life Sciences, Epidemiology, Public Health, Health Informatics, Healthcare Administration, or a related field.
• Preferred: Advanced degree (Master’s or Ph.D.) in Epidemiology, Public Health (MPH), Health Economics, or Life Sciences.

FOR US BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $151,200.00 - $226,800.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.