Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Office



Job Description



COMPANY: Thermo Fisher Scientific Inc.


LOCATION: 168 Third Avenue, Waltham, MA 02451


TITLE: Sr. Clinical Project Manager


HOURS: Monday to Friday, 8:00 am to 5:00 pm


DUTIES: • Develop relevant clinical strategies and plans; • Ensure clinical research programs are designed and conducted in accordance with company standard operating policies and procedures (SOPs), Good Clinical Practices (GCP), ISO20916:2019, In-Vitro Diagnostics Device Regulation (IVDR) and FDA regulations; • Identify project risks, develop and implement mitigation plans; • Organize, plan, and lead cross-functional, highly sophisticated and businesscritical projects, with a focus on development, registration, and commercialization of ImmunoDiagnostics products; • Guaranty audit and inspection preparedness of all assigned projects; • Responsible for corrective action plans at individual sites and across trial; • Report project progress to governance boards and raise issues to IDD management. • Lead cross-functional, highly-complex and business critical clinical projects; • Hold accountability and responsibility of all operational and safety deliverables of assigned company sponsored studies. • Can work remotely or telecommute.


TRAVEL: Up to 20% domestic travel and international required. Can work remotely or telecommute.


REQUIREMENTS: MINIMUM Education Requirement: Bachelor's degree, or foreign equivalent, in Infectious Diseases, Microbiology, or a related scientific field of study. MINIMUM Experience Requirement: 5 years of global clinical research management experience in medical devices with Vitro-Diagnostics or related experience. Required knowledge or experience with: • Medical terminology, clinical trial design and statistics both for product registration and post-market follow-up; • Guidelines, systems for clinical trial management and international regulations and practices (knowledge of CE IVDR required and IVD FDA/CFDA strong asset); • Expertise with ISO20916:2019; 56086028.v1-IMMIGRATION • Build innovative infrastructure and standard processes; • Clinical Trial Management System (CTMS); • Electronic Document Management System (EDMS).


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