Senior Clinical Trial Associate

🔥 0 minutes ago

🌐 Poland, Romania, +1 more countries – Remote

🇵🇱 Poland – Remote 🇷🇴 Romania – Remote 🇷🇸 Serbia – Remote

💵 zł110k - zł120k / year

⏰ Full Time

🟠 Senior

✨ Clinical Trial Associate

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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 logistical support to one or more global study management teams through all phases of clinical study management • Develop and maintain relationships with study management team members, affiliate teams, and vendors • Assist the Clinical Trial Manager with communication between the study management team and affiliates • Coordinate global study supplies using designated systems • Coordinate and organize study-related meetings and develop presentation materials • Consolidate study information for trackers and databases • Support protocol feasibility, country, and site selection processes • Support technical and logistical study processes • Track and maintain study information and documentation and report study progress • Maintain study management data, team contact details, country contacts, and distribution lists • Track Health Authority, IRB, and IEC submissions and approvals in CTMS; identify delays and escalate issues • Provide submission and supplementary documentation to affiliates or Product Development Regulatory • Maintain completeness of the study-level Trial Master File under CTM direction • Identify and contribute to best practices and process improvements • Incorporate learnings and recommendations from study debriefs and best practices

🎯 Requirements

• At least 3 years experience as a project specialist at global level in clinical trials • Strong computer skills, including CTMS, EDMS, Excel, and Word • Knowledge of and compliance with ICH-GCP Guidelines, international and local regulations, Parexel procedures, and client-specific procedures • Good oral and written communication skills • Ability to prioritize multiple tasks and achieve project timelines • Effective problem-solving skills • Ability to mentor and train less experienced staff as appropriate • Active participation as a process and/or platform Subject Matter Expert (SME) with minimal LM oversight • Fluent English and Polish skills, oral and written • Relevant qualification or equivalent experience required • High school diploma; ideally a degree in life science or another related background is preferred

🏖️ Benefits

• Premium salary • Attractive benefits • Medical care plan: Health, Dental & Vision • Life Assurance • Excellent work environment • Culture of teamwork and collaboration • Innovative technology • Excellent training • Annual performance-based bonus plan for eligible roles • Annual salary review for eligible roles • Total rewards incentives for eligible roles