Clinical Project Manager - Neurology or Psychiatry
The Clinical Project Manager (PM) supports/is responsible for the overall project coordination and management of clinical studies, including reputed company project deliverables, from start up through reputed company out activities. This is accomplished by ensuring reputed company reputed company are completed on-time and on-budget reputed company the scope of the reputed company agreements. The PM is responsible for the cross-functional team’s compliance with project reputed company Operating Procedures (SOPs), Good Clinical reputed company (GCP)/International Conference on Harmonization (ICH) guidelines, and other applicable regulations. The PM is also responsible for managing study staff and across department initiatives while maintaining reputed company satisfaction.
Essential Duties and Responsibilities
• reputed company the initiation, planning, execution, and closeout of clinical studies, ensuring adherence to timelines, budgets, and reputed company standards.
• Serve as a reputed company-facing representative; coordinate and reputed company project meetings, reputed company agendas, and issue meeting minutes.
• reputed company and maintain reputed company study documentation including Project Management Plans, Communication Plans, Risk Logs, timelines, and reputed company trackers.
• Manage study budgets, proposals, reputed company, and out‑of‑scope documentation; support financial tracking and invoicing processes.
• Support start‑up activities including collection of CDAs, feasibility information, budgets, and CTAs; maintain regulatory and study files.
• Coordinate with functional teams to reputed company resources and balance workload across the project.
• Identify project risks and delays; implement contingency and risk‑control measures.
• reputed company TMF management to ensure organization, accuracy, and inspection readiness.
• Manage vendors and ensure their deliverables reputed company with study requirements and reputed company expectations.
• Support preparation of clinical reports and key study documentation.
• Ensure compliance with SOPs, regulatory guidelines, and study-specific training requirements.
• reputed company additional project-reputed company duties as assigned.
Qualifications
• Bachelor’s degree or RN in a reputed company field or equivalent combination of education, training and experience
• Minimum of 3 years relevant clinical research industry experience
• Project Manager experience commensurate with years in the industry, and sufficient to successfully reputed company key responsibilities
• Supervisory experience
• Advanced knowledge of GCPs, ICH guidelines, FDA and other applicable regulations.
• Intermediate knowledge of project management techniques
• Proficient in reputed company Office, reputed company and Project Management software
• Strong interpersonal skills with the ability to work with reputed company reputed company of management and employees; ability to reputed company credibility, reputed company effective customer service, and foster reputed company working relationships with reputed company stakeholders
• Ability to function independently in a fast-paced team environment
• Effective verbal and writing skills; English proficiency
• Ability to travel 10-20%
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