Senior Clinical Study Manager (Europe)

at  Thermo Fisher Scientific

KNOWLEDGE, SKILL, AND ABILITY

• Demonstrate Leadership to develop, empower and guide personnel to meet objectives.
• Excellent interpersonal written and verbal skills to communicate effectively across cross-functional departments and cross-sites.
• Proficient knowledge of medical terminology, clinical trial design and statistics both for product registration and post-market follow-up.
• 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, allergy and/or auto-immunity strongly preferred.
• Ability to develop and implement solutions to address identified problems.
• Excellent study management, interpersonal and time management skills.
• Willingness and ability to travel oversea for up to 30-50% of time.
• Ability to work in a complementary team and sophisticated environment and adapt to changing priorities.
• Ability to provide clear directions and mentorship to others.
• Vendor selection and management experience
• 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+ experience preferred in global clinical research management experience in medical devices with a minimum specifically in in-vitro diagnostics area.
• Advanced written and spoken English and additional European language preferred.
  Apply today! http://jobs.thermofisher.com
  Please send in your application, including a cover letter, CV (in one document) in English, apply via http://jobs.thermofisher.com/. Please apply as soon as possible, the position will be filled as soon as suitable candidate is found.
  Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of sex, transgender identity or expression, ethnicity, religion or other belief, disability, sexual orientation or age on, or other non-disability related technical issues will not receive a response.

• 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 crafted 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.
• Review clinical evaluation plans and reports for scientific rigor.
• Identify project risks and develop & implement mitigation plans.
• Coordinate, plan, and lead cross-functional, highly sophisticated, and business-critical projects, with a focus on development, registration, and commercialization of ImmunoDiagnostics 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.