Opportunity Description
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,...
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,...
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