Work Schedule

Environmental Conditions

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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