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About the Role

The Study Manager leads the operational planning, execution, and closure of non-interventional, observational research projects. This role ensures operational excellence, cross-functional alignment, vendor oversight, budget management, and timely delivery of high-quality Real-World Evidence (RWE). 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.

Responsibilities

Lead the end-to-end operational planning, implementation, management, and closeout of global and regional observational studies.
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, 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).
Lead cross-functional development and review of study-specific operational plans, protocol synopses, observational research protocols, statistical analysis plans (SAPs), and feasibility assessments.
Oversee informed consent form (ICF) templates, patient recruitment strategies, site selection, electronic Case Report Form (eCRF) design, and site contracting for prospective studies.
Oversee data abstraction form design, EHR/claims database licensing, data transfer specifications, data linkage agreements, and variable mapping documents for retrospective studies.
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.
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.
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.
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.

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

Skills

Observational study execution
Good Pharmacoepidemiology Practice (GPP)
Data privacy compliance
Cross-functional study team leadership
Real-World Evidence (RWE)
Real-World Data (RWD)
Good Clinical Practice (GCP)
HIPAA
GDPR
ISPOR
ISPE
eTMF
CTMS
EDC
Data governance platforms

Location

Remote

Work Type

Remote
Full-time

Experience Level

6+ years of research project management experience
3+ years specifically focused on leading observational studies

Education Level

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

Salary/Compensations

$151,200.00 - $226,800.00

Benefits

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

About the Company

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.

Equal Opportunity

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.