Thermo Fisher Scientific

Clinical Research Manager

Thermo Fisher Scientific • $90K — $120K *
Austin, TX 78745In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree or equivalent in a relevant field
  • 2+ years of prior experience in clinical research management
  • Understanding of Phase I processes and clinical study operations
  • Familiarity with FDA regulations and ICH GCP guidelines
  • Strong organizational and prioritization skills

Responsibilities

  • Act as the primary contact for clinical site-related aspects of studies
  • Coordinate with internal departments to meet contractual deliverables
  • Oversee clinical and administrative aspects of clinical projects
  • Manage IRB submissions and maintain regulatory documents
  • Develop and maintain a risk register with the Principal Investigator
  • Collaborate with finance to manage study-related budgets
  • Provide oversight for contracted vendor services

Benefits

  • Standard Monday-Friday work schedule
  • Work in an office/laboratory and clinical environment
  • Opportunity to engage in diverse clinical trial settings
  • Exposure to impactful patient-related research
  • Collaborative work with various internal and external teams
Full Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

The Clinical Research Manager manages all aspects of assigned clinical trials involving patient and healthy subject populations in both inpatient and outpatient settings. The role involves acting as liaison between functions (i.e. PM, investigator, research team, etc.) The Clinical Research Manager ensures client requirements and specifications are communicated to the research teams and any issues/questions raised by the research team or investigators are communicated back to the project leads and client (as needed) for resolution.

What You'll Do:
• Serve as a primary point of contact for the project team and the business unit for clinical site related aspects of the study.
• Collaborate with internal departments to ensure deliverables are met as defined within the contract and study timeline.
• Manage all clinical and administrative aspects of a clinical project, including site level study set-up, recruitment, conduction and data collection.
• Manage IRB submissions including creation of study specific informed consent forms, SAE notifications and maintenance of the regulatory file and documents.
• Collect feedback from various departments to create a risk register for each study and maintains and updates the register throughout the study. Work with the Principal Investigator to ensure that a risk mitigation plan (RMP) is finalized and reviewed by the safety committee prior to study conduct.
• Work closely with finance department to manage fiscal aspects of study conduct while meeting sponsor requirements and adhering to the protocol, SOPs and contract.
• Provide vendor oversight when services are contracted.

Education & Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities:
• Knowledge of Phase I processes and strong knowledge of clinical study operations
• Knowledge of FDA regulations and ICH GCP guidelines
• Solid computer skills with working knowledge of Microsoft Office applications
• Good time management and multi-tasking skills
• Solid written and verbal communication skills
• Strong organizational and prioritization skills with the ability to prioritize workload and adapt to changing study needs
• Favorable consulting skills to act as a liaison between external and internal groups
• Knowledge of budgeting/forecasting/planning projects.

Working Conditions and Environment:
• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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