Senior Clinical Operations Specialist
1 week ago
Company Overview
Thermo Fisher Scientific Inc. is a global leader in the life sciences industry, dedicated to accelerating research, solving complex scientific challenges, and driving technological innovation. With a commitment to integrity, intensity, innovation, and involvement, our team of 100,000+ colleagues works together to make a positive impact on the world.
Job Description
We are seeking an experienced Clinical Research Associate (CRA) Manager to join our dynamic team at Thermo Fisher Scientific Inc. As a key member of our clinical operations group, you will be responsible for overseeing the coordination and management of clinical trials, ensuring compliance with regulatory requirements, and providing exceptional customer service to our clients. Your expertise will play a critical role in shaping the success of our clinical research programs and delivering high-quality results to our customers.
About the Role
The CRA Manager will provide leadership and guidance to junior CRAs, ensuring they have the necessary tools, resources, and support to excel in their roles. This position requires a strong understanding of clinical trial design, execution, and management, as well as excellent communication and interpersonal skills. You will work closely with cross-functional teams, including study managers, data managers, and biostatisticians, to ensure seamless project delivery. A successful candidate will possess a deep understanding of Good Clinical Practice (GCP), ICH guidelines, and applicable regulations. The ability to think critically, problem-solve, and navigate complex issues is essential for this role.
Key Responsibilities
* Provide technical leadership and guidance to junior CRAs
* Oversee the planning, coordination, and execution of clinical trials
* Ensure compliance with regulatory requirements, GCP, and ICH guidelines
* Collaborate with study managers, data managers, and biostatisticians to deliver high-quality projects
* Develop and implement training programs for junior CRAs
* Foster strong relationships with clients and internal stakeholders
* Participate in process improvement initiatives to enhance operational efficiency
Requirements
* Bachelor's degree in a life sciences-related field or equivalent experience
* Minimum 3 years of experience in clinical research, preferably in a CRA role
* Strong understanding of clinical trial design, execution, and management
* Excellent communication, interpersonal, and leadership skills
* Ability to think critically and problem-solve
* Proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint
* Willingness to travel up to 60% of the time, with occasional overnight stays
Benefits
Thermo Fisher Scientific Inc. offers a comprehensive benefits package, including competitive salary, bonus potential, and opportunities for professional growth and development. Our company values diversity, equity, and inclusion, and we are committed to creating a workplace where everyone can thrive. If you are passionate about clinical research and want to be part of a dynamic team that is making a difference in people's lives, please apply today
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