Project Specialist

Responsibilities

• Partners with the Project Manager (PM) to ensure overall Project Delivery through coordination and oversight of the cross-functional project team
• Manage and track budgets related to vendor projects including tracking of supplies and invoices. Track out of scope services and assists in preparing Change Orders.
• Tracks supplies, invoices, and budgets relating to vendor management, as appropriate.
• Ensures projects are audit ready
• Creates and manages the required project systems, SOP indices, and study team lists, as applicable. Manages study team/contact lists, system access requests, and e-mail distribution lists as required
• What we are searching for:
• Basic knowledge of ICH/GCP regulations
• Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• Basic knowledge of project management terminology and guidelines
• Strong computer skills in MS office suite required
• This role is offered as a 1 year Fixed Term Contract on Premier Research payroll. Applications should be immediately available or only have a short notice period to be considered.

Benefits

Additional Information

Premier Research is looking for a Project Specialist to join our Business Operations team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here.

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