The posting
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Project Manager - CNS based in the United States.
This role leads the coordination and management of clinical studies from initiation through closeout, ensuring projects are delivered on time, within budget, and according to agreed scope. You will serve as a key client-facing partner while coordinating cross-functional teams, vendors, and study stakeholders throughout the clinical trial lifecycle. The position combines project leadership, financial oversight, risk management, documentation, regulatory compliance, and team coordination. You will help maintain high standards of quality and inspection readiness while ensuring study teams follow applicable SOPs, GCP, ICH, and regulatory requirements. The role offers broad ownership of study operations, including timelines, budgets, contracts, TMF management, and project documentation. You will work in a collaborative, fast-paced clinical operations environment where strong organization, communication, and independent judgment are essential. This is a fully remote US-based, full-time opportunity with approximately 10–20% travel.
Accountabilities
- Lead the initiation, planning, execution, and closeout of clinical studies while maintaining timelines, budgets, scope, and quality standards.
- Coordinate cross-functional project teams and allocate resources to balance workloads and support successful study delivery.
- Act as a client-facing representative by leading project meetings, preparing agendas, documenting decisions, and maintaining effective stakeholder communication.
- Develop and maintain core study documentation, including Project Management Plans, Communication Plans, risk logs, timelines, milestone trackers, and related project records.
- Manage study budgets, proposals, contracts, out-of-scope activities, financial tracking, and invoicing processes.
- Support study start-up activities, including collection of confidentiality agreements, feasibility information, budgets, and clinical trial agreements.
- Maintain appropriate regulatory and study files throughout the clinical trial lifecycle.
- Identify project risks, delays, and operational challenges and implement appropriate contingency and risk-control measures.
- Oversee Trial Master File management to maintain organization, accuracy, completeness, and inspection readiness.
- Manage vendors and monitor their deliverables to ensure alignment with study requirements, timelines, and quality expectations.
- Coordinate preparation of clinical reports and other key study documentation.
- Ensure cross-functional teams comply with SOPs, GCP, ICH guidelines, applicable regulations, and study-specific training requirements.
- Support broader department initiatives and perform additional project-related responsibilities as needed.
- Bachelor’s degree, RN qualification, or equivalent combination of education, training, and relevant experience.
- At least 3 years of relevant clinical research industry experience.
- Clinical Project Manager experience appropriate to the level of responsibility required for successful study management.
- Supervisory experience and demonstrated ability to coordinate and guide project teams.
- Advanced knowledge of Good Clinical Practice, ICH guidelines, FDA requirements, and other applicable clinical research regulations.
- Intermediate knowledge of project management principles, methodologies, and techniques.
- Proficiency with Microsoft Office, Adobe, and project management software.
- Strong organizational and interpersonal skills, with the ability to work effectively across all levels of management and with internal and external stakeholders.
- Strong client service skills and the ability to build credibility, maintain trust, and foster productive professional relationships.
- Ability to work independently while contributing effectively within a fast-paced team environment.
- Strong written and verbal communication skills with professional English proficiency.
- Strong attention to detail and ability to manage multiple priorities across complex clinical projects.
- Willingness and ability to travel approximately 10–20%.
- Fully remote work within the United States.
- Full-time employment.
- Opportunity to lead clinical studies from start-up through closeout.
- Broad exposure to clinical operations, project management, regulatory compliance, vendors, and client relationships.
- Opportunity to work on CNS-focused clinical research and contribute to the development of new therapies.
- High level of responsibility across study timelines, budgets, quality, risk management, and delivery.
- Collaborative environment with cross-functional and client-facing responsibilities.
- Professional experience across GCP, ICH, FDA, TMF, clinical documentation, and clinical trial operations.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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