Project Manager

Work Schedule Standard Office Hours (40/wk) Environmental Conditions Office

Job Description

Join Us as a Project Lead/Project Manager - Make an Impact at the Forefront of Innovation. - The Project Manager serves as the Project Lead and primary sponsor contact and is 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. - The role involves leading the cross functional project team to meet or exceed deliverables. - As part of the Study Management Team (SMT), is accountable for the implementation and execution of study plans to support successful clinical trial delivery, including the following: - Responsible for the delivery of the cross-functional project (time, cost, quality) by working closely with Global trial and functional leads. - Ensures escalation pathways adhered to internally and externally (Rules of Engagement – communication pathways). - On projects where the scope requires, ensures 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). - Ensures 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. - Establishes, communicates and manages customer expectations to achieve optimal delivery during the project - Drives Risk Identification and Issue Resolution at project level - Ensures project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements. - Responsible for vendor management, where required - Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment - Effective oral and written communication and presentation skills - Proactive, solutions oriented and adaptable to changing priorities and situations - 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 - Ability to negotiate, persuade and influence others, including a cross-cultural awareness Education & Experience 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. - Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. - Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills, Abilities: - 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. - Ability to establish and execute operational plans. - 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. - Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment - Effective oral and written communication and presentation skills - Proactive, solutions oriented and adaptable to changing priorities and situations Preferred Skills & Credentials: - An advanced degree in a related field. - Investigator site and/or monitoring experience. - Functional Service Provider (FSP) experience. - Prior neurology therapeutic experience required, rare-disease experience also preferred - Ability to travel domestically and internationally