Neuchâtel, Switzerland
25 year of global clinical trial experience both within device and pharma studies from phase I till IV, pre and post-marketing. Specialties: clinical development, clinical research, clinical research scientist, clinical trial project and people-management, clinical trial monitoring, global clinical trial regulations, global health authorities submissions until approval, IRB/IEC, data-management, EDC, statistics, data generation and analysis, clinical study reporting, medical writing, medical and study presentations, abstracts, publications, posters, protocol and ICF writing, study plans development, steering committee and data monitoring committee management, safety monitoring committee, CRO and vendor management, clinical trial management systems, managing, coaching, mentoring, directing, ICH-GCP, Declaration of Helsinki, FDA regulations, ISO 14155, SOP's, WI's, policy analysis, languages and microsoft tools. Hands-On, Team-Player, Hard-worker, Self-Motivated, Challenges Motivate me and Willing to Learn.
This position leads the Clinical Science program in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team. Manages and supervises a team of senior and junior Clinical Scientists to execute trial level activities for multiple trials. Ensures consistency across studies and provide oversight of all clinical studies within assigned area. May represent the Clinical Scientist function in various process improvement initiatives and/or cross functional activities. Serves as a key cross functional collaborator; initial point of escalation cross functions.
The Clinical Scientist Team Lead reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. • Leads the Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team • Manages and supervises a team of senior and junior Clinical Scientists to execute trial level activities for multiple trials • Ensures consistency across studies and provide oversight of all clinical studies within assigned area • May serve as a Clinical Trial Lead or Co-Lead as needed • May represent the Clinical Scientist function in various process improvement initiatives and/or cross functional activities • Serves as a key cross functional collaborator; initial point of escalation cross functions
Program implementation, including oversight of all aspects of clinical study development, start-up, conduct, and close out. The principal clinical researsch scientist works closely within the clinical function as well as cross-functionally to provide high quality and timely deliverables. The principal clinical research scientist is the key contact for study related clinical/scientific activities.
Overseeing and coordination of all the clinical and scientific activities of assigned studies. This is in order to guarantee the quality and timeliness of study planning, implementation, execution and close-out. The Clinical Research Scientist is the key contact for study related clinical/scientific questions and issues.
Clinical Operations Project and People management from start-up till close-out of clinical trial portfolio
Project Manager for global pharma studies
Overal responsibilities of running the clinical trials and mentoring of junior project managers.
Project Management of Clinical Trials
Project Management of Clinical Trials