Clinical Trial Manager - Contract - Remote, US
Take the lead on complex international clinical studies, driving operational excellence from start-up to study close-out.
Proclinical is seeking a Clinical Trial Manager to lead the execution of mid- to late-stage global clinical studies from start-up through close-out and clinical study reporting. This is a contract role with the potential to transition into a permanent position.
Primary Responsibilities:
The successful candidate will oversee day-to-day trial management, coordinate cross-functional teams, and manage external vendors to ensure studies are delivered on time, within budget, and in compliance with quality and regulatory standards. This role requires hands-on involvement in trial execution, proactive problem-solving, and accountability for study performance metrics.
Skills & Requirements:
- Bachelor's degree in a scientific or health-related field.
- Experience managing clinical trials, preferably in neurology or CNS therapeutic development.
- Strong knowledge of ICH guidelines, GCP, and global regulatory requirements.
- Proven ability to manage global clinical studies, including coordination with investigators, CROs, and vendors.
- Solid understanding of project management principles, including timeline, resource, and budget management.
- Excellent communication and interpersonal skills, with the ability to influence and drive team performance.
- Proactive problem-solving mindset with the ability to anticipate issues and implement creative solutions.
The Clinical Trial Manager's responsibilities will be:
- Plan and execute mid- to late-stage clinical trials in neurology, ensuring operational excellence, data quality, and compliance with protocols, GCP, and global regulations.
- Lead daily clinical trial operations, coordinating with cross-functional teams such as Clinical Development, Data Management, Biostatistics, Regulatory, and Safety.
- Oversee CROs and external vendors, including co-monitoring activities, to ensure adherence to timelines, budgets, and quality expectations.
- Drive critical milestones such as site activation, patient enrollment, retention, data cleaning, and database lock, addressing operational challenges proactively.
- Review and approve vendor-generated plans and study documentation to ensure alignment with protocols and regulatory standards.
- Monitor study progress using operational metrics, maintaining dashboards, timelines, and financial tracking, and providing timely updates to stakeholders.
- Identify and manage operational risks, proposing mitigation strategies to minimize impact on timelines, quality, and patient safety.
- Ensure inspection and audit readiness, including oversight of Trial Master File (TMF) maintenance and close-out.
- Contribute to operational planning, regulatory deliverables, and continuous improvement of clinical operations processes.
If you are having difficulty in applying or if you have any questions, please contact Alex Kelly at a.kelly@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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