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