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ICH-GCP
Responsibilities:
- Execute site qualification, initiation, monitoring, and close-out visits, ensuring compliance with ICH-GCP and protocols.
- Verify informed consent, source documents, and CRF accuracy, driving query resolution and escalating issues.
- Manage IP inventory, ISF/TMF reconciliation, and support audit readiness.
Qualifications:
- Bachelor’s degree or RN in a related field or equivalent combination of education and experience.
- Knowledge of Good Clinical Practice and ICH Guidelines.
- Strong computer, communication, and interpersonal skills; ability to travel up to 75%.
Company Culture:
- Partner with a diverse team of experts in a therapeutically aligned structure for seamless collaboration.
- Engage in career progression, technical training, and a supportive environment focused on patient impact.
Syneos Health
Syneos Health is a leading fully-integrated life sciences services organization that partners with innovators across drug development and commercialization to accelerate progress. With over 25,000 colleagues globally, the company fosters an inclusive culture focused on career development, peer recognition, and a passion for delivering life-changing therapies.