This position is listed on behalf of a partner company, who manages all applications and next steps.
The partner is looking for a Senior Clinical Project Manager - CNS based in the United States.
Responsibilities
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.
Act as a client-facing representative by leading project meetings, preparing agendas, documenting decisions, and maintaining stakeholder communication.
Develop and maintain core study documentation, including Project Management Plans, Communication Plans, risk logs, timelines, milestone trackers.
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 contingency and risk-control measures.
Oversee Trial Master File management to maintain organization, accuracy, completeness, and inspection readiness.
Manage vendors and monitor their deliverables.
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.
Requirements
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.
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.
Strong client service skills.
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%.
Conditions
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.
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.