Clinical Trial Operations Specialist

Responsibilities

• Lead the planning, coordination, and conduct of clinical trial activities in accordance with ICH-GCP
• Collaborate with Clinical Trial Leaders, regional operating units, and external stakeholders to ensure seamless trial execution
• Manage trial supplies distribution, tracking, and planning in coordination with relevant functions
• Oversee clinical trial documentation, including the preparation, quality checking, and archiving of essential documents for the Trial Master File (TMF)
• Maintain and oversee internal and external clinical trial systems to ensure data accuracy and timely safety reporting
• Monitor trial progress, perform plausibility checks, and implement corrective actions as needed
• Support trial wrap-up activities, including data cleaning and the generation of Clinical Trial Report (CTR) appendices

Requirements

• University degree or comparable professional education
• At least 5 years of experience in clinical trials
• Strong knowledge of US FDA, EMA, and PMDA regulations
• Proficiency in MS Office (Word, PowerPoint, Excel, Outlook)
• Excellent communication and interpersonal skills
• Ability to work effectively in a multi-cultural, cross-geographical environment

Preferred Qualifications

• Experience with Documentation Management Systems and Trial Management Systems
• Proven ability to manage complex project timelines and budgets
• Demonstrated leadership and problem-solving capabilities in a clinical research setting

Benefits

• Flexible work arrangements including remote, in-office, and hybrid options
• Supportive and inclusive work environment with a focus on relationship building
• Opportunities for significant career progression and professional development
• Exposure to diverse therapeutic areas and a wide range of global clients

About the Company

Parexel is a global leader in clinical research, dedicated to helping bring life-changing treatments to market faster. We combine expertise and empathy to contribute to clinical research, driven by a patient-centric mission to improve lives worldwide.