Sr Clinical Project Manager - ALS

 Posted 5 days ago
     
10+ years experience
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AI Summary

Lead complex Amyotrophic Lateral Sclerosis (ALS) clinical trials from start-up to close-out, ensuring delivery within scope, budget, and timelines. Manage multidisciplinary teams and serve as the primary point of contact for sponsors and internal stakeholders.
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 Sr Clinical Project Manager in our neuroscience business unit focusing on ALS projects, 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
  • Provide leadership of one or more complex Amyotrophic Lateral Sclerosis (ALS) projects 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
  • Minimum 10 years’ experience in clinical trials (pharma and/or CRO), with at least 5 years as Project Manager.
  • Recent Amyotrophic Lateral Sclerosis (ALS) study experience
  • Proven ability to create strong relationships with small sponsor stakeholders including CEOs
  • Extensive multinational study experience
  • Strong knowledge of ICH-GCP and relevant regulations

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