Country Study Operations Manager – Sponsor Dedicated

Responsibilities

• Develop and coordinate Phase 1 clinical research studies, ensuring all aspects of the study are meticulously planned and executed
• Implement clinical research protocols and ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines
• Collaborate with principal investigators, research subjects, client teams, and clinic operations teams to facilitate smooth communication and coordination
• Plan and manage logistics and resource usage for clinical trials, including scheduling, budgeting, and resource allocation
• Track study progress and ensure alignment with project milestones, client deliverables, and budget, providing regular updates to stakeholders
• Prepare and present study reports and updates to stakeholders, including detailed analysis of study data and progress
• Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes or updates
• Provide guidance and support to lower-level professionals and team members, fostering a collaborative and supportive work environment
• Identify and resolve any issues or challenges that arise during the course of the study, ensuring timely and effective solutions
• Maintain accurate and comprehensive documentation of all study-related activities, ensuring transparency and accountability.

Requirements

• Bachelor's degree in a related field (e.g., life sciences, clinical research)
• Minimum of 3 years of experience in clinical trial management or a related field
• In-depth knowledge of clinical research processes and regulations
• Strong project management and organizational skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Proficiency in using clinical trial management software and tools
• Certified Clinical Research Professional (CCRP) or equivalent certification preferred.
• Strong analytical and problem-solving skills
• Attention to detail and accuracy
• Ability to manage multiple projects and priorities simultaneously
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.