Clinical Study Manager (Homebased)

Clinical Study Manager (Homebased)
Responsibilities

+ Own operational accountability for study-level time, cost, and quality deliverables for a global Phase II pan-tumor trial with multiple indications and stages.

+ Lead the development and maintenance of the clinical study plan, including critical path activities, interdependencies, and timelines, using Microsoft Project or similar project management tools.

+ Develop and drive the cross-functional Clinical Study Oversight Plan under the guidance of the study team leader, and ensure consistent adherence by internal teams, CROs, and vendors.

+ Provide operational input into protocol profiles, final protocols, and protocol amendments, ensuring feasibility and operational excellence across global regions.

+ Lead and coordinate document review for protocols and amendments, and support or lead related medical writing tasks such as informed consent forms, CRF guidelines, investigator brochures,...