Clinical Scientist

Responsibilities

• Support the CDM in effective implementation of CDP for day to day interaction with LOCs, study centers, external partners, preparation and follow-up of IDMC, trial steering committees, advisory committees;
• Coordination of implementation of regional/global studies (CRTs) and Onco-RD studies in close collaboration with clinical operations;
• Contribute to development of briefing documents, regulatory dossiers, protocols, end of study reports with scientific writer and CDM;
• Within ASCI BU, ensure dedicated project planning, tracking and executional management across the clinical functions for specific projects (CDM, Biostat, SciWri, CSC, Data Management);
• Monitors the clinical project in terms of milestones, i.e. proposes corrective actions to CDM/Lead CDM by reviewing and incorporating input from Clinical Operations (both central and regional) in terms of timing, feasibility, performance and availability of resources
• Owns the “Clinical Project Master Plan” (ensuring quality and accuracy of the information): creates and keeps clinical project plans updated and communicates global clinical project timelines in a cohesive and timely manner
• Actively participate in Value Driven Allocation (VDA) process (in collaboration with clinical operation and Lead CDM/CDM)
• Organizes and prepare the CPT meeting with CDM; actively participates in a variety of meetings if his/her presence is required (e.g. Project Team, Logistics, etc); ensures that effective meetings management practices are adopted for assigned CPT’s.
• Ensures that progress and information circulation/sharing tools are developed in a harmonized manner amongst CPT members

Profile

• PhD in sciences (Life Sciences preferably), pharmacist or equivalent experience
• Excellent knowledge and understanding of Clinical Study Management roles and activities
• Advanced knowledge ICH-GCP.
• Excellent knowledge of written & spoken English, Knowledge of French is an asset.
• Knowledge of Regional organization and understanding of Local Operating Countries structure.
• Intensive knowledge of ASCI projects, CDP, clinical oncology in general
• At least 5 years experience in clinical study conduct in pharmaceutical industry
• At least 2 years experience in similar function (clinical management)
• Experience in a matrix/complex/multi-disciplinary environment
• Experience in clinical research with oncology products at an international level