At a Glance
- Tasks: Lead innovative research projects that transform patient lives through real-world evidence.
- Company: Join Jazz Pharmaceuticals, a global biopharma leader dedicated to life-changing medicines.
- Benefits: Enjoy competitive pay, flexible vacation, and comprehensive health benefits.
- Other info: Collaborative environment with opportunities for mentorship and career growth.
- Why this job: Make a real impact in healthcare while working with cutting-edge research methodologies.
- Qualifications: 6+ years in project management, preferably in biotech or pharma, with observational study expertise.
The predicted salary is between 51750 - 63250 £ per year.
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.
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.
Required Knowledge, Skills, and Abilities
- Experience: 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.
Senior Manager, Real World Evidence (Cambridge) employer: Jazz Pharmaceuticals
Jazz Pharmaceuticals is an exceptional employer, offering a dynamic work culture that prioritises innovation and collaboration in the biopharma industry. With a strong commitment to employee growth, we provide numerous opportunities for professional development and a competitive benefits package, including flexible paid vacation and comprehensive health insurance. Located in vibrant cities like London and Cambridge, our employees enjoy a stimulating environment that fosters creativity and teamwork while making a meaningful impact on patients' lives worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Real World Evidence (Cambridge)
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We think you need these skills to ace Senior Manager, Real World Evidence (Cambridge)
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Jazz Pharmaceuticals!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Jazz Pharmaceuticals that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Jazz Pharmaceuticals!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Jazz Pharmaceuticals, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Jazz Pharmaceuticals
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Jazz Pharmaceuticals that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Jazz Pharmaceuticals’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
