Description
Syneos Health is seeking a Clinical Trial Manager I to join their Clinical Solutions team. As a Clinical Trial Manager I, you will develop and coordinate Phase 1 clinical research studies, ensuring all aspects of the study are meticulously planned and executed.
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
Qualifications:
- 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
Certifications:
- Certified Clinical Research Professional (CCRP) or equivalent certification preferred
Necessary Skills:
- 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