Sr. Clinical Project Manager - Epilepsy
P95 United States
Pharmaceutical Manufacturing · 201-500 employees
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About the role
The Senior Clinical Project Manager will lead complex clinical trials from start-up to close-out, ensuring all project milestones are met within scope, budget, and timeline. They will act as the primary point of contact for sponsors while managing multidisciplinary teams and driving compliance with regulatory standards.
What they look for
Requirements
Candidates must possess at least 7 years of clinical trial experience, including a minimum of 5 years as a Project Manager within a CRO environment. A biomedical degree and specific expertise in rare epilepsy studies are required for this role.
Full description
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 Manager in 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.
- 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
- 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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