Description
Syneos Health is seeking a Clinical Trial Manager to join their team in Taiwan.
As a Clinical Trial Manager, you will be responsible for performing site qualification, site initiation, interim monitoring, site management activities, and close-out visits.
Key responsibilities include:
- Conducting site qualification, site initiation, and close-out visits
- Monitoring site activities to ensure compliance with regulatory requirements and protocol
- Assessing site processes and conducting source document reviews
- Verifying informed consent and patient safety
- Managing investigational product inventory and reconciliation
- Reviewing investigator site files and trial master files
- Documenting activities and tracking progress
- Collaborating with site personnel and project teams
- Preparing for and attending investigator meetings and sponsor meetings
- Providing guidance on audit readiness and supporting preparation for audits
Requirements:
- 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
- Good computer skills and ability to adapt to new technologies
Syneos Health offers a range of benefits, including career development and progression, supportive line management, technical and therapeutic area training, and total rewards programs.