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The Clinical Operations Lead (COL) leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
The COL may perform site monitoring as needed to support the flexible capacity model.
The COL is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
Key Accountabilities:
Trial and Site Administration:
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 o...