Working from our office location in Mexico City, as an Initiation Clinical Site Manager (ICSM) you will be the direct point of contact with assigned sites and accountable for quality and delivery during the start-up phase. Duties will include Preparation, negotiation, and facilitation of
Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments, Informed Consent Forms (ICF); Conduct remote Qualification Visits (QVs), Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
To be considered for this opportunity you must have clinical trials experience as a CRA, study nurse or site coordinator ideally with a university degree in a health-related discipline. Understanding of GCP and relevant regulations plus knowledge of submissions and ICF customizations is expected. This is a virtual team environment and your strong interpersonal and communication skills will help you to succeed. Fluency in English is required.
QualificationsSignificant regulatory and/or site experience in clinical trials Educated to degree level preferred (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experienceSound awareness of all relevant regulations, including GCPFluency in English is required