Work ScheduleStandard (Mon-Fri)
Environmental ConditionsOffice
Job DescriptionThe 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.
• 6 + years in clinical operations management, managing clinical trials per quality, timeline, and budget expectations, preferably with a Sponsor company and a CRO.
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.
