Consultant – RWE Project Manager

Jobtailor

Paris

Sur place

EUR 70 000 - 100 000

Plein temps

Il y a 3 jours
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Résumé du poste

Jobtailor seeks an experienced Real-World Evidence (RWE) Project Manager to lead design and execution of post-marketing observational studies in France. You will manage large data partnerships, coordinate cross-functional teams, and ensure regulatory compliance, including local RIPH classification.

The candidate should have at least 3 years in a similar RWE PM role, a Pharm.D. or Master’s in Epidemiology/Biostatistics/Public Health/Health Data Science, and fluent English.

Qualifications

  • 3+ years in a Real-World Evidence project management role.
  • Experience with RWE study design
  • Fluent English and ability to communicate cross-functionally.
  • Proven expertise in real-world data.
  • Strong clinical project management skills.

Responsabilités

  • Design and implement post-marketing observational studies, including retrospective and prospective projects.
  • Analyze opportunities and assess feasibility of study projects from Global teams.
  • Advise on local regulatory requirements, especially RIPH classification.
  • Lead ongoing studies and manage large data partnerships and CROs.
  • Monitor Early Access Programs implementation and outcomes.
  • Coordinate internal and external stakeholders (MSLs, Medical Advisors, Data Managers, Biostatisticians, CROs).

Connaissances

Real-World Data
Clinical Project Management
Regulatory Compliance
Analytical Mindset
Fluent English

Formation

Pharm.D.
Master’s in Epidemiology
Master’s in Biostatistics
Master’s in Public Health
Master’s in Health Data Science

Description du poste

  • Design and implement post-marketing, observational, retrospective, and prospective clinical studies
  • Analyze opportunities and assess the technical, methodological, and regulatory feasibility of study projects originating from Global
  • Advise and challenge Global teams regarding local regulatory requirements, particularly RIPH classification
  • Lead ongoing studies, including high-volume data partnerships and large databases
  • Actively contribute to the implementation and monitoring of Early Access Programs
  • Supervise, review, and validate reports and data summaries provided by partner CROs
  • Coordinate internal and external clients, MSLs, Medical Advisors, Data Managers, Biostatisticians, and CROs
Requirements
  • Pharm.D. or a Master’s degree specializing in Epidemiology, Biostatistics, Public Health, Health Data Science, or a related field
  • At least 3 years of significant experience in a similar RWE / Real-World Evidence Project Manager role within the pharmaceutical or biotech industry, or at a CRO
  • Analytical mindset, proactivity, autonomy, and the ability to assess project feasibility
  • Fluent English required
  • Proven expertise in real-world data
  • Strong clinical project management skills
Core Competencies

Demonstrates expertise in designing and implementing clinical studies, with a strong focus on real-world evidence and regulatory compliance. Proficient in project management within the pharmaceutical or biotech industry, ensuring effective collaboration with cross-functional teams.

Highest-signal resume keywords
  • Real-World Evidence Expertise
  • Clinical Project Management
  • Regulatory Feasibility Assessment
  • Data Analysis and Reporting
  • Fluent English Communication
ATS Optimization Keywords
Hard Skills
  • Clinical Study Design
  • Data Analysis
  • Project Management
  • Regulatory Compliance
  • Epidemiology
  • Biostatistics
  • Health Data Science
  • Report Validation
  • Data Summary Review
  • Observational Study Implementation
Soft Skills
  • Analytical Mindset
  • Proactivity
  • Autonomy
Certifications & Qualifications
  • Pharm.D.
  • Master’s Degree in Epidemiology
  • Master’s Degree in Biostatistics
  • Master’s Degree in Public Health
  • Master’s Degree in Health Data Science
Industry Keywords
  • Pharmaceutical Industry
  • Biotech Industry
  • CRO
  • RWE
  • Early Access Programs
  • High-Volume Data Partnerships
  • Local Regulatory Requirements
  • RIPH Classification
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