Description
Syneos Health is seeking a Clinical Trial Manager II to join their team in Shanghai. The successful candidate will be responsible for managing clinical trials, ensuring compliance with regulatory requirements, and maintaining high-quality standards.
Job Responsibilities
- Perform site qualification, site initiation, interim monitoring, site management activities, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient.
- Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site.
- Develop and implement site-specific actions plans and communicate/escalate serious issues to the project team.
- Maintain a working knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
- Utilize available hardware and software to support the effective conduct of the clinical project data review and capture.
- Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
- Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
Qualifications
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage required travel of up to 75% on a regular basis.
Benefits
Syneos Health offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program.