The posting
Independently performs, coordinates and oversees all aspects of the clinical site monitoring services, assessing protocol and regulatory compliance as per Alimentiv’s and sponsor’s standard processes, ICH/GCP guidelines and local regulation. Serves as the primary liaison between the sponsor/Alimentiv and investigative sites by playing a critical role in the execution of clinical study plans. Provides guidance and mentoring CRA I and II, collaborating effectively with cross-functional stakeholders in a dynamic, results-driven and high-accountability environment. Perform CRA Assessment Visits and participate in audits/inspections, when required.
Site Monitoring activities (55-60%)
Site Management activities (15-20%)
Site Recruitment and Setup (15-20%)
Mentoring and Internal Initiatives (5-10%)
QUALIFICATIONS
ADDITIONAL KNOWLEDGE / SKILLS
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