Sr. Clinical Project Manager - Epilepsy

United StatesRemoteFull-timesenior

OperationsProject Manager

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Requirements Summary

Academic degree, preferably in a biomedical or related scientific field. Previous experience working within a Contract Research Organization (CRO) is required.

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OperationsProject Manager

This is an opportunity for an experienced clinical research professional to lead complex clinical trials focused on epilepsy, with particular emphasis on rare epilepsy indications. You will oversee studies from start-up through close-out, ensuring delivery against agreed scope, timelines, budgets, and quality standards. Working within a specialized neuroscience team, you will coordinate multidisciplinary experts and serve as a trusted day-to-day partner to sponsors. The role offers considerable autonomy, close collaboration with experienced clinical operations teams, and the opportunity to contribute to studies addressing significant unmet medical needs. Your expertise will help advance clinical development while maintaining the highest standards of regulatory compliance and operational excellence.

Lead the delivery of complex clinical trials in CNS, with a strong focus on rare epilepsy studies, ensuring milestones and services meet sponsor expectations and agreed project scope, timelines, and budgets.
Oversee clinical projects throughout their full lifecycle, from study start-up to close-out.
Develop study-specific documentation in collaboration with Compliance and relevant study teams.
Monitor project progress against plans, key performance indicators, timelines, and budgets, implementing adjustments when necessary.
Identify, assess, and proactively mitigate project risks and operational challenges.
Provide clear and timely progress updates to sponsors, internal stakeholders, and steering committees.
Serve as the primary day-to-day contact for sponsors and project teams, building effective working relationships and maintaining alignment.
Manage project finances and contribute to proposals, budget development, and bid defense meetings.
Resolve complex project challenges through effective communication, collaboration, and stakeholder engagement.
Identify opportunities for process improvements and contribute to the continued development of the clinical project management function.

Requirements

~1 min read

Academic degree, preferably in a biomedical or related scientific field.
Previous experience working within a Contract Research Organization (CRO) is required.
Direct experience managing epilepsy clinical trials, ideally involving rare epilepsy indications, is essential.
At least 7 years of clinical trial experience within the pharmaceutical industry and/or CRO environment.
Minimum of 5 years of experience in clinical project management, including significant experience within a CRO.
Experience in additional neurological or neuroscience indications is highly desirable.
Extensive experience managing multinational clinical studies and coordinating international teams.
Strong knowledge of ICH-GCP guidelines and applicable clinical research regulations.
Excellent command of English, with strong written and verbal communication skills.
Proven ability to establish and maintain trusted relationships with sponsor stakeholders, including senior executives and CEOs.
Strong project leadership, organizational, financial management, and problem-solving capabilities.
Ability to work autonomously while collaborating effectively with multidisciplinary teams and external stakeholders.