Trial Management Specialist
2 days ago
Clinical Operations Manager Job Description:
">This role will oversee clinical operations for multiple studies, ensuring timely and quality delivery of clinical trial management services. The ideal candidate will have previous experience in clinical trials, with a strong understanding of Good Clinical Practice (GCP) and regulatory requirements.
">Responsibilities:
">- Manage site interactions, ensuring compliance with GCP, ICH Guidelines and regulatory requirements.
- Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan.
- Coordinate initial and ongoing training for the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines.
Qualifications:
">- Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
- Minimum 2 years of experience in clinical trials, with a strong understanding of GCP and regulatory requirements.
- Excellent communication, presentation and interpersonal skills, with ability to work effectively with cross-functional teams.
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