Project Manager - REMS Team - Remote based in the US

About the role

• Work Schedule
• Standard (Mon-Fri)
• Environmental Conditions
• Office

About the role

Position requires experience managing full service clinical trials with a preference for those who have REMS specific experience.

Join Us as a 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.

What You'll Do

• Serve as the primary contact between the sponsor and the organization at the project level.
• Ensure escalation pathways adhered to internally and externally (Rules of Engagement - communication pathways).
• On projects where the scope requires, 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).
• Accountable for the overall delivery of the cross-functional project (time, cost, quality).
• Ensure financial stewardship at a project 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 (RBQM/RESOLVE).
• Ensure project team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements.

Education & Experience Requirements

• 3-5 years' REMS experience required
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years').

Additional information

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

• 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 (CTMS, Preclarus, Clarity)
• 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
• Strong understanding of the key principles of project management (time, quality, cost), including solid financial acumen
• Sound interpersonal and customer service skills, including the ability to lead, motivate and coordinate cross-functional project teams
• Good judgment and decision making skills and capable of applying critical and analytical strategic thinking skills to manage complex/ambiguous situations
• Ability to negotiate, persuade and influence others, including a cross cultural awareness.

Working Conditions and Environment

• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.