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Sr. Clinical Project Manager - Epilepsy

Role overview

Qualifications

  • Academic degree, preferably in a biomedical field
  • CRO experience required
  • Epilepsy trial experience required
  • Minimum 7 years’ experience in clinical trials (pharma and/or CRO), with at least 5 years as Project Manager

Responsibilities

  • Provide leadership in the delivery of services and key milestones to ensure project delivery according to client expectations
  • Develop study-specific documentation in collaboration with Compliance and study teams
  • Monitor progress against plans, KPIs, and budgets; adjust as needed
  • Identify and mitigate risks proactively

Key facts

Hard skills

Other skills

  • Leadership
  • Problem Solving
  • Communication

About the company

P95 logo

P95

  • Clinical Research (CRO)
  • SME
  • 201–500
P95 is a leading global provider of epidemiology and clinical solutions with a specialty focus on vaccines and infectious diseases.  Headquartered in Belgium, P95's full-service CRO solutions span 5 continents, with 300 staff and experience across 30 countries. P95 is dedicated to delivering flexible, customer-centrical solutions, powered by a team that is passionate about driving positive change in global health. The P95 group has over 25 years of experience and offers a range of high-quality services including: - Clinical Trials Phase I-IV - Epidemiology and RWE - Vaccine Development Consulting - Study Start-up and Regulatory - Clinical Monitoring - Home Nursing - Sample Management - Medical Monitoring - Pharmacovigilance - Data Management - Biostatistics - Medical Writing - Qualitative Research

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Job description

About

P95 Julius Clinical is a leading global, full-service Clinical Research Organization (CRO) delivering integrated clinical development and real-world evidence solutions across five continents. Formed through the strategic merger of P95 and Julius Clinical, the organization combines P95's leadership in infectious diseases, vaccines, and real-world evidence with Julius Clinical's expertise in central nervous system, cardio-metabolic, renal, and rare diseases, creating a unique mid-sized CRO with scale, agility and scientific depth. With regional hubs in Africa, Latin America, North America, Southeast Asia, and Europe, we operate with a team of 500 professionals and a track record that includes more than 1000 clinical trials conducted in over 50 countries. We offer comprehensive CRO capabilities supporting both full-service and modular approaches across the entire development lifecycle and post-marketing phases for pharmaceutical, biotech, and public health partners.


As a Senior Clinical Project Managerin our neuroscience business unit, remotely in the U.S., you will lead complex clinical trials from start-up to close-out, ensuring delivery within scope, budget, and timelines. You will manage multidisciplinary teams, act as the primary contact for sponsors, and drive excellence in compliance with ICH-GCP, protocols, and SOPs. We are looking to strengthen our current epilepsy expertise and add another employee (or contractor) with strong rare epilepsy study background. Our ops teams are highly experienced, turnover is low, and our CPMs have a lot of autonomy. 


Responsibilities
  • With expertise in CNS and specifically, rare epilepsy studies, the Sr CPM will provide leadership in the delivery of services and key milestones to make sure that projects are delivered according to the client expectations and project scope, time schedules and budget
  • Develop study-specific documentation in collaboration with Compliance and study teams;
  • Monitor progress against plans, KPIs, and budgets; adjust as needed
  • Identify and mitigate risks proactively
  • Report progress to sponsors, internal stakeholders, and steering committees
  • Act as the day-to-day contact for sponsors and project teams
  • Drive process improvements and contribute to departmental growth
  • Manage project finances and support proposals and bid defense meetings
  • Resolve complex challenges through effective stakeholder engagement

Requirements
  • Academic degree, preferably in a biomedical field
  • CRO experience required
  • Epilepsy trial experience required
  • Minimum 7 years’ experience in clinical trials (pharma and/or CRO), with at least 5 years as Project Manager and some significant CRO experience
  • Experience with other Neuro indications is ideal
  • Extensive multinational study experience 
  • Excellent command of English
  • Strong knowledge of ICH-GCP and relevant regulations
  • Proven ability to create strong relationships with small sponsor stakeholders including CEOs

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