Project Manager - FSP Trial Lead - Remote based in the US

About the role

The Project Manager serves as the Project Lead and primary sponsor contact, accountable for the overall delivery of the project (quality, time, cost) on behalf of the organization. Additionally, the Project Manager establishes and communicates customer expectations to the project team and ensures that escalation pathways are adhered to internally and externally.

Responsibilities

• Deliver the cross-functional project (time, cost, quality) by working closely with Global trial and functional leads.
• Ensure escalation pathways adhere to internal and external communication pathways.
• Ensure clear delineation in responsibilities and communication pathways for secondary project leads (such as lead in a specific region, lead for a specific vendor(s) or subset of delivery).
• Ensure financial stewardship at a trial level by demonstrating an intimate understanding of the contract, resource alignment to budget, management of Out-of-Scope activity, drive the Con Mod process/negotiations and team execution to timelines.
• Establish, communicate, and manage customer expectations to achieve optimal delivery during the project.
• Drive Risk Identification and Issue Resolution at project level.
• Ensure project team compliance with organization policies, SOPs, ICH-GCP, regulatory and project specific requirements.
• Responsible for vendor management, where required.
• Delegate and effectively prioritize own and workload of project team members in a frequently changing environment.
• Effectively communicate and present information.
• Proactively identify and resolve issues and adapt to changing priorities and situations.

Requirements

• B.A. or B.Sc. in a scientific discipline.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) with 2+ years of project/trial management.
• Related scientific and clinical expertise and exceptional project-management, risk-assessment, contingency-planning, and communication skills.
• Extensive knowledge of clinical development related to one or more trial phases (I, II, III), as well as cross-functional drug development.
• Expertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines and regulatory requirements for clinical development.
• Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems.

Qualifications

• Advanced therapeutic area knowledge and clinical development guidelines and directives.
• Sound interpersonal and customer service skills, including the ability to lead, motivate and coordinate cross-functional project teams.
• Prior neurology therapeutic experience required, rare-disease experience also preferred.