Senior Clinical Trial Associate

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

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

• Provides logistical support to one or more global study management teams (SMT) • Develops and maintains effective working relationships with SMT members, affiliate team members, and vendors • Assists Clinical Trial Manager (CTM) with effective communication between the SMT and Affiliates • Coordinates the management of all global supplies utilizing the designated systems in collaboration with the CTM throughout the course of the study • Coordinates and organizes study related meetings in collaboration with the Clinical Program Leader (CPL) and CTM including the development and production of presentation materials • Consolidates study information for study trackers and databases • Supports the protocol feasibility, country, and site selection process • Supports CTM in technical and logistical study processes • Tracks and maintains study information and documentation and reports on study progress • Maintains accurate tracking and reporting of Study Management data • Coordinates and maintains the contact details of core SMT and Clinical Operations teams, including country contacts and distribution lists • Oversees the timely tracking of Health Authority (HA)/IRB/IEC submissions and approvals in CTMS • Identifies any delays and raises issues to the CTM and appropriate Country Study Manager (CSM) • Provides IRB/IEC and HA submission documentation and all other supplementary documentation to affiliates or Product Development Regulatory (PDR), as appropriate • Maintains and ensures the completeness of the Study-Level Trial Master File (TMF) in accordance with SOP requirements under the direction of the CTM • Identifies and contributes to areas of best practice and process improvements • Proactively incorporates learnings and recommendations from other study debriefs and best practices • Organizes agendas and minutes for team meetings • Manages touchpoint study area according to global standards, including set-up, access rights, and maintenance of study-related documents • Manages client system platform access rights and follows up on site training progress • Ensures appropriate tracking and dissemination of Safety Reports during studies • Assists in the coordination of activities to ensure CRO and vendor delivery against the contracted scope of work • Coordinates communication for defined tasks and tracking information between the study team and vendor • Complies with all required training curricula • Completes timesheets accurately as required • Submits expense reports as required • Updates CV as required

🎯 Requirements

• Bachelor’s degree, preferable life sciences or nursing equivalent • Minimum of 2 years’ experience working as project specialist in clinical research or health career-related industry or equivalent of education and experience • Experience of working as part of larger global teams with a proven ability to make an active contribution to the team’s performance and team working • Knowledge of ICH/GCP • Solid experience in TMF • Experience in WORD, EXCEL, PowerPoint, other software and system • Fundamental understanding of filing systems and organizational tools • Proficiency in written and spoken English

🏖️ Benefits

• Medical care plan: Health, Dental & Vision • Life Assurance • Excellent work environment • Culture of teamwork and collaboration • Innovative technology • Excellent training