Clinical Affairs Senior

at  Thermo Fisher Scientific

THERMO FISHER SCIENTIFIC INC. IS SEEKING A CLINICAL AFFAIRS SENIOR TO JOIN OUR WORLD-CLASS TEAM OF RESEARCHERS. AS A LEADER IN THE SCIENTIFIC COMMUNITY, WE ARE DEDICATED TO ENABLING OUR CUSTOMERS TO MAKE THE WORLD HEALTHIER, CLEANER, AND SAFER. AT THERMO FISHER SCIENTIFIC, WE VALUE DIVERSE EXPERIENCES, BACKGROUNDS, AND PERSPECTIVES, AND WE BELIEVE THAT COLLABORATION AND INCLUSION ARE KEY TO DRIVING INNOVATION AND SOLVING COMPLEX SCIENTIFIC CHALLENGES.

In this role, you will have the unique opportunity to lead clinical study operations to include clinical trial budgeting and study management activities. You will collaborate with cross-functional teams to support clinical planning and study execution Additionally, you will analyze clinical affairs operations, identifying areas for improvement and implementing corrective measures.

QUALIFICATIONS:

• Bachelor’s degree in Science or equivalent experience, with a proven track record of success in clinical trial budget managment.
• A minimum of 4 years of relevant clinical research experience.
• Strong working knowledge of Good Clinical Practices (GCP), FDA and EU regulations, and current industry practices related to the conduct of clinical trials.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with multidisciplinary teams
• Organized and attentive to detail, with a strong commitment to achieving high-quality outcomes
• Strong analytical and problem-solving abilities
• Ability to work effectively in a fast-paced and dynamic environment
• Proficient with clinical study management tools (e.g. eTMF, EDC).
  Join our team at Thermo Fisher Scientific and be part of a world-class organization that is dedicated to making a difference in the scientific community. Apply today!

• Interact with investigative sites, vendors, and other functional areas to ensure successful execution of clinical studies.
• Coordinate the planning of clinical studies to ensure that deliverables are completed on time and within budget
• Develop and manage internal clinical project database.
• Update and/or generate internal Standard Operating Procedures (SOPs) to ensure GCP compliance
• Support clinical study management activities to include, IRB/EC submission and approval activities and generating clinical site documentation in compliance to trial protocols.
• Participate on cross functional core project teams to ensure clinical deliverables are aligned with Business objectives.