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.Skills Required
Project Management, Good Clinical Practice, Communication Skills, Organizational Skills, Interpersonal Skills