Clinical Study Administrator – CTA

🔥 3 minutes ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🖥️ Administration

👻 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

• Assist in coordination and administration of clinical studies from start-up through execution and closeout • Serve as the local administrative main contact and work with CRAs and/or the Local Study Associate Director • Set up, populate, and maintain client tracking and communication systems such as CTMS, VCV, and SharePoint • Coordinate and track study materials and equipment • Coordinate administrative tasks during studies, audits, and regulatory inspections • Lead practical arrangements and support preparation of internal and external meetings • Liaise with internal and external participants and vendors • Prepare, contribute to, and distribute presentation materials for meetings, newsletters, and websites • Interface with investigators, external service providers, CRAs, data management, and global clinical solutions representatives • Maintain the local electronic Trial Master File and Investigator Site File, including document tracking • Upload essential documents promptly to maintain eTMF inspection readiness • Prepare study documents for final archiving and support CRA closeout activities • Produce and maintain study documents with template and version compliance • Manage document layout, language control, copying, printing, distribution, and email archiving • Collect, prepare, review, and track documents for regulatory applications • Assist with submissions to EC/IRB and Regulatory Authorities • Create or import clinical-regulatory documents into global electronic management systems • Support electronic applications and submissions according to Submission Ready Standards • Prepare or support site-level contracts • Prepare, support, or perform HCO/HCP payments in accordance with local regulations

🎯 Requirements

• Knowledge of ICH-GCP and local requirements • Ability to work with clinical trial management systems and electronic management systems, including CTMS, SharePoint, VCV, and ANGEL • Ability to handle clinical-regulatory documents according to technical standards, including Submission Ready Standards (SRS) • Ability to support EC/IRB and Regulatory Authority submissions • Ability to perform document collection, tracking, maintenance, archiving, and version control • Ability to support site-level contracts and HCO/HCP payments in accordance with local regulations • English and local-language translation and spell-checking capability, as required