R&D - CSO - Clinical Operations Study Lead - BJ

Clinical Operations Study Lead (COSL) is the operational lead in clinical studies, accountable for the proper execution and delivery of his/her trial for all aspects of the clinical study (end-to-end). He/she is accountable for implementing the operational plan (OP) developed by the COPL for the clinical trial he/she has been assigned. COSL leads a cross-function team to execute the clinical study as outlined in the OP and ensures all trial deliverables are met according to study timelines, within budget, and having the highest quality standards GCP (Good Clinical Practice) /ICH (International Conference on Harmonization), Standard Operating Procedures (SOPs) and/or Quality Documents (QDs). COSL leads the execution of the study with integrity and suitable for regulatory review.

Key interfaces for COSL are the members of Core Study Team, which consists of representatives from CSUs through their Clinical Operations Study Country Lead (COSCL), Data Management, Vendor Management, ...