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Job Description
To lead Local Study Team at country level (Malaysia) to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with sponsor’s Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. The Clinical Lead may perform site monitoring as needed to support the flexible capacity model. The Clinical Lead is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
Responsibilities:
Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with sponsor’s Procedural Documents, ICH-GCP and local regulations.