Clinical Trial Manager

We are seeking a highly organized and experienced Clinical Trial Manager to oversee the development, coordination, and implementation of Phase 1 clinical research studies. This role is crucial for meticulously planning logistics, tracking study progress against milestones, and ensuring strict compliance with all regulatory requirements.

Roles and Responsibilities

• Develop and coordinate Phase 1 clinical research studies, ensuring meticulous planning and execution.
• Implement clinical research protocols and ensure strict 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.
• Prepare and present study reports and updates to stakeholders, including detailed analysis of study data.
• Ensure adherence to global and regional regulations and guidelines, staying up-to-date with any changes.
• Provide guidance and support to lower-level professionals and team members.
• Identify and resolve any issues or challenges that arise during the course of the study.
• Maintain accurate and comprehensive documentation of all study-related activities.

Skills Required

• Bachelor's degree in a related field (e.g., life sciences, clinical research).
• 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.
• Strong analytical and problem-solving skills.
• Attention to detail and accuracy.
• Ability to manage multiple projects and priorities simultaneously.
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
• A Certified Clinical Research Professional (CCRP) or equivalent certification is preferred.