Sr. Clinical Project Manager - Epilepsy
About this role
P95 Julius Clinical has become AKEURA, a specialist contract research organization (CRO) helping sponsors advance medicines across their full lifecycle. Our dual expertise in early- through late-phase clinical development and real-world evidence is delivered by hands-on clinicians, scientists, and epidemiologists, drawing on more than 25 years of experience.
We’re built on the belief that a team of the right people, giving everything they’ve got to the needs of the study, will outperform any other approach. Our team of more than 500 experts spanning five continents has delivered more than 1,000 studies in over 75 countries, including regions where patients are hardest to reach. AKEURA exclusively focuses on three therapeutic areas: neuroscience, infectious diseases and vaccines, and cardiometabolic diseases. Across each, we bring the experience, reach and hands-on expertise to give every promising medicine the study it deserves.
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
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.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
Originally posted on Himalayas
