Clinical Study Team Assistant II – FSP

🔥 16 hours ago

🌐 Mexico, Argentina, +2 more countries – Remote

🇲🇽 Mexico – Remote 🇦🇷 Argentina – Remote 🇧🇷 Brazil – Remote 🇨🇱 Chile – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Assistant

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Provide study-level operational support to the Core Study Team from study start-up through close-out and submission • Manage and oversee Study Team shared spaces, TMF maintenance and compliance, Study Management Platform, registries, and Clinical Trial Management systems • Analyze, interpret, and follow up on study metrics • Track study-level information and coordinate with cross-functional study team members • Initiate and coordinate study-level forms and data entry across clinical operations applications and systems • Provide reporting on clinical trial data, budgets, and timelines • Perform quality control of essential clinical trial, CSR, and regulatory submission documentation • Manage engagement of Independent Oversight Committees • Support inspection readiness activities and oversight of Clinical Trial Budget spend • Provide logistical and operational support for Investigator Meetings • Provide status updates to the CSTL and actively contribute to Core Study Team meetings • Coordinate and prioritize multiple study tasks while meeting timelines and quality standards • Serve as a Subject Matter Expert or Technical Resource for clinical trial processes, systems, and tasks • Support short-term Clinical Operations special projects • Support CSTA Managers with onboarding training; train and mentor new hires and junior CSTAs • Identify continuous improvement opportunities with CSTA Managers • Manage conflicting priorities and own time to meet targets, timelines, work plans, and deliverables • Complete assigned client and EP training and adhere to EP and Client SOPs and processes

🎯 Requirements

• Bachelor’s of Science degree or equivalent and 3 years’ experience within the CRO/Pharmaceutical industry • Proficient in Microsoft Office applications (Outlook, Word, PowerPoint, Excel) • Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research • Proficiency in written and spoken English • Compliance with ICH-GCP, SOPs, and regulatory regulations