Note: The job is a remote job and is open to candidates in USA. Proclinical Staffing is recruiting for a Clinical Trial Manager contract role. The position leads mid- to late-stage global clinical studies from start-up through close-out, overseeing trial operations, cross-functional teams, CROs, vendors, milestones, budgets, quality, and regulatory compliance.
Responsibilities
- 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
Skills
- • 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
Benefits
- Remote, US
- Contract role with the potential to transition into a permanent position
Company Overview
Company H1B Sponsorship