Real-World Evidence Manager (f/m/d), PAUL HARTMANN AG
Responsibilities:
Design and implement RWD and RWEstrategies to generate clinical, safety, and economic evidence for medtech products
Collaborate with cross-functional teams within Evidence Generation Department (Clinical Trials, Evidence Synthesis, Health Economics, and Diagnostic/Prognostic Research), and beyond, including regulatory, clinical affairs, market access, marketing, and sales to integrate RWE into product development and lifecycle management
Develop study protocols, including observational studies, registries, and post-market surveillance, to gather and analyze real-world data
Lead data extraction, cleaning, analysis, and interpretation from diverse real-world data sources such as electronic health records (EHR), claims data, patient registries, and wearables
Communicate RWE findings through reports, scientific publications, white papers, and presentations to internal stakeholders, regulatory authorities, and external audiences
Ensure compliance with applicable regulatory guidelines and industry standards for data privacy, security, and ethical use of patient data
Stay up to date with emerging trends and technologies in real-world data and evidence generation, and apply innovative methods to optimize RWD and RWE strategies
Qualifications:
Advanced degree in epidemiology, biostatistics, health economics, public health, data science, or related fields
3+ years of experience in generating real-world data (RWD) and evidence (RWE), preferably in medtech, pharma, or healthcare
Proven experience with real-world data sources (EHR, claims, registry data) and RWE studies for regulatory or HTA purposes
Proficiency in statistical programming and data analysis tools (SAS, R, Python) and familiarity with RWD platforms (e.g., Flatiron, IQVIA)
Strong knowledge of real-world study designs (retrospective cohort, case-control, registry-based) and global regulatory requirements (FDA, EMA)
Expertise in GDPR, data privacy laws, and health economic models with evidence synthesis
Strong project management, communication skills, and experience in medtech or digital health solutions
Benefits:
Flexible working conditions, such as flexible working hours and mobile working
Attractive ways of combining work and family life, e.g. childcare subsidy
30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement
Company pension plan with attractive employer contribution incl. matching model for deferred compensation
Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop
Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass)
Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc.
Job Bike Leasing
Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform