Job Information
ThermoFisher Scientific Sr. Clinical Project Manager in Cambridge, Massachusetts
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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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.