Sr. Clinical Study Manager

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Position Scope: The mission of the Clinical Affairs group within Medical and Scientific Affairs is to create customer value for ImmunoDiagnostic Division (IDD) by providing clinical evidence for product pre-launch and post-launch across the portfolio. Main responsibilities for the unit are: Own IDD Clinical Affairs planning, execution, and reporting. Develop timely and efficient clinical strategies to support product claims (mainly autoimmunity portfolio). Liaise with Regulatory Affairs organization to complete prioritized product registration plans in selected geographical areas (USA and EU. Liaise with the Medical Directors to align disease definition and study population characterizations Liaise with R&D organization to align product specifications to be fulfilled and patient cohorts to be targeted. Liaise with Commercial Operations organizations to ensure desired products are available for sales on the territory. Liaise with Marketing organization to leverage on key customers and KOLs within clinical trials and support building sales supporting arguments on top of registration-related claims. Essential Responsibilities: Reporting to the Global Director Clinical Affairs, the Senior Clinical Project Manager will be responsible for: Lead cross-functional, high-complex and business critical clinical projects. Hold accountability and responsibility of all operational and safety deliverables of assigned company sponsored studies. Develop relevant clinical strategies and plans. Ensure clinical research programs are designed and conducted in accordance with company standards operating policies & procedures (SOPs), Good Clinical Practices (GCP), ISO20916:2019, In-Vitro Diagnostics Device Regulation (IVDR) and FDA regulation. Generate clinical evaluation plans and reports for FDA and IVDR submissions. Generate relevant Trial Master File documents and support CRAs for TMF quality checks and completeness. Be able to build a CRF (Case Report Form) starting from the clinical study plan and protocol/s Generate CPSP (Clinical performance study plan) according to the study needs and in collaboration with several projects’ functions Support CRAs during clinical study initiation and close out. Identify project risks and develop & implement mitigation plans. Organize, plan, and lead cross-functional, highly sophisticated and business-critical projects, with a focus on development, registration, and commercialization of Immunodiagnostic products. Guaranty Audit and Inspection preparedness of all assigned projects. Be responsible for corrective action plans at individual sites and across trial. Report project progress to governance boards and raise issues to IDD management. Provide decision support and recommendations for critical decisions to IDD management. Help identify and drive assigned department goals. Knowledge, Skill, and Ability: Demonstrate Leadership to develop, empower and guide personnel to meet objectives. Excellent interpersonal written and verbal skills to communicate optimally across cross-functional departments and cross-sites. Proficient knowledge of medical terminology, clinical trial design and statistics. Proven detailed knowledge of 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 required. Knowledge of immunology, auto-immunity and/or allergy strongly preferred. Ability to develop and implement solutions to address identified problems. Excellent project management, organizational and time management skills. Willingness and ability to travel oversea for up to 30-50% of time. Ability to work in a diverse team and dynamic environment and adapt to changing priorities. Ability to provide clear directions and guidance to others. Desire to use experience to build innovative infrastructure and “standard processes”. Knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and skill in using Microsoft Office suite. Education Bachelor’s degree in biological sciences, nursing or related medical/scientific field or equivalent work experience. 5 years minimum preferred global clinical studies experience (in-vitro medical devices experience preferred) with a minimum specifically in project management. Advanced written and spoken English and additional European language preferred. Apply now!