Description
Syneos Health is seeking a Clinical Trial Manager to join their team. As a Clinical Trial Manager, you will play a crucial role in 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 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
What We Offer
- Opportunities for career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Commitment to our Total Self culture – where you can authentically be yourself