Senior Clinical Project Manager - CNS

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.

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 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%.

Benefits:

• 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.