Clinical Scientist Lead

hace 2 semanas


Girona, Gerona, España Daiichi Sankyo Europe A tiempo completo

Position Overview: We are seeking a highly qualified Clinical Scientist to join our team at Daiichi Sankyo Europe. As a key member of our Clinical Development department, you will play a crucial role in the development and execution of clinical trials.

Key Responsibilities:
Provide strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan;
Review patient population and protocol compliance for consistency with study strategy;
Develop biomarker strategy in collaboration with Translational Medicine/Clin Pharm;
May act as Clinical Study Leader (CSL);
Study Planning and Execution: Provide input on major milestones of trial, clinical trial plan, and contingency planning;
Analyze and update management on potential risks to study deliverables;
Provide input on ICF creation;
Oversees recruitment and retention;
Establish and implement contingency plans for shortfalls;
Consult & recruits members for DSMB and/or adjudication committee setup;
Study outputs: Draft responses to IRBs and Health Authorities;
Collaborate with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK/PD measurements;
Review emerging clinical data regularly;
Leads dose-escalation meetings;
Performs quality assessment with Delivery Lead e.G



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