Project Specialist

Overview

As Project Specialist within Premier Research’s Business Operations, you enable successful delivery of clinical projects by coordinating cross-functional teams, ensuring audit readiness, and managing project documentation and vendor budgets. You’ll partner with the Project Manager to keep communications clear and stakeholders aligned, while maintaining systems and change control. This role places you at the heart of complex life sciences programs that bring medicines, devices, but diagnostics to patients. You’ll work in a collaborative, growth-oriented environment that values your voice and development.

Pay / Benefits

• flexible work arrangements
• growth opportunities
• balance between work and life
• collaborative culture
• professional development
• employee recognition

Responsibilities

• Coordinate project delivery with cross-functional teams under the Project Manager
• Facilitate internal/external communications, schedule meetings, create agendas, capture minutes, and maintain action/decision logs
• Maintain project contact lists and distribute study newsletters as needed
• Manage budgets and vendor-related expenses, including tracking invoices and supplies
• Track out-of-scope services and assist in preparing Change Orders
• Ensure audit readiness and maintain project systems, SOP indices, and study team lists
• Manage study team contacts, system access requests, and distribution lists

Key requirements

• Associate’s degree (or equivalent) in life sciences,Medicine, Pharmacy, Nursing or related field with minimum 2 years of clinical research experience or Bachelor’s degree with minimum 1 year of relevant experience
• 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

• Cross-functional collaboration
• Attention to detail
• Effective communication
• MS Office Suite
• Budget tracking
• Vendor management

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