Lead the Clinical Sub Team (CST). Plan, conduct, and report all clinical trials of an Alcon Program or Project.
Contributes to the project development plan, including high-level clinical trial design.
Works with Therapeutic Unit Head (TUH) and Project Heads (PH), to create and understand the clinical aspects of the development plan and clinical trial requirements.
Provides input to the development plan and study concept sheets.
Designs studies aligned with the overall program and project plan.
Leads the Clinical Sub Team, in particular, take on responsibility for planning clinical trials, writing study protocols based on concept sheets, and writes study supporting documents.
Contributes to site selection and CRO selection process.
Conducts clinical studies, and along with CM (if assigned) ensures study conduct is within timelines and budget.
Ensures the accuracy of trial information in Clinical Trial Management System (CTMS).
Contributes to ongoing scientific review of data (data cleaning, safety reporting and related activities.
Ensures accuracy and timely completion of clinical study reports.
Writes clinical content of submission dossiers to regulatory authorities, including, e.g.,
Briefing Books, NDAs, CE-Technical Files, and PMAs.
Serves as Core Project Team Member and is the primary contact for the Project Head (PH).
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