Clinical Trial Associate, Senior Project Specialist

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Assist with organizing, updating and maintaining tracking systems and tools to support the conduct of clinical study from start-up to closeout • Assist with the coordination and development of study management tools, monitoring tools, study manuals and training materials and presentations • Schedule meetings, prepare and distribute meeting agendas, minutes, and follow-up action items for study teams • Set up, organize and maintain study files and shared spaces in accordance with study requirements • Coordinate and track study training • Manage study sample and supply tracking and support interactions with vendors as needed • Support the Study Management team with specific projects • Communicate with study team members and identify and address study-related issues in collaboration with the study team • Perform routine quality checks on trial-level documents to ensure completeness and accuracy • Support timely, complete and compliant archiving in the TMF • Participate in company, departmental and project team meetings, including Investigator Meetings • Assist with basic financial and budget tracking activities related to the clinical trial

🎯 Requirements

• BS/BA degree or degree in healthcare field required • Experience supporting clinical operations activities in a similar role: 1+ years in a pharma or biotech organization or 2 years of experience in a CRO environment • Basic knowledge of drug development and clinical operations processes • Foundational knowledge of clinical trial process and supports study activities in accordance with ICH-GCP and Code of Federal regulations • Effective written and verbal communication skills, with the ability to work collaboratively within study teams • Strong organization and interpersonal skills • Foundational experience with eTMF systems (VeevaVault preferred) and basic knowledge of essential documents to file study documents accurately with guidance • Strong attention to detail • Able to prioritize and manage multiple tasks with competing deadlines • High sense of urgency and commitment to excellence in the successful execution of deliverables • Demonstrates ability to identify issues and escalate appropriately to support timeline adherence • Proficient with MS Office Suite (Excel, Word, PowerPoint) and project tracking tools