Thermo Fisher Scientific

Clinical Team Manager/Sr. (CTM) - FSP

Thermo Fisher Scientific • $100K — $130K *
US-Anywhere
+ 2 other locationsRemote
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree with 5+ years of relevant experience.
  • Experience in Monitoring or Study Management preferred.
  • Strong background in Neuroscience preferred.
  • Client-dedicated experience is a plus.
  • Demonstrated supervisory and leadership skills.

Responsibilities

  • Manage monitoring operations and quality for assigned studies, ensuring compliance with regulations.
  • Develop clinical tools and study plans, collaborating with Biogen CSO and leading team meetings.
  • Coordinate with regional CMLs for effective communication and oversight.
  • Ensure timely deliverables, regulatory compliance, and effective resource management.
  • Conduct trip report reviews to align with study timelines.
  • Identify and report site performance issues, including trend analysis.
  • Generate monitoring plans and assist with site visits and client meetings.

Benefits

  • Competitive remuneration and annual incentive plan bonus.
  • Comprehensive healthcare options.
  • Employee benefits focused on health and well-being.
  • Opportunities for career development within a forward-thinking organization.
  • Cultural emphasis on integrity, involvement, and innovation.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Summarized Purpose:

Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities.

Essential Functions:
  • Manages all aspects of monitoring operations and quality for assigned studies, ensuring compliance with ICH GCP and applicable local regulations
  • Develops clinical tools and study plans, collaborates with Biogen CSO (to include but not limited to CCSLs) and leads team meetings to maintain timelines, resources, and quality. Serves as clinical subject matter expert for protocol and point of escalation for site manager as applicable
  • May include reginal coordination with regional CMLs.
  • Ensures timely deliverables, monitors trials, communicates with study sites, coordinates start-up activities, addresses regulatory requirements and provides input on forecast estimates and resource management.
  • Completes trip report reviews in compliance with study plan timeline.
  • Issue escalation per plan, responsible for identifying and reporting site performance issues, trend analysis
  • May perform accompanied site visits with site manager and may attend meetings with Sponsor to discuss, but not limited to country/region start up progress, trending and issue identification/escalation, and general site/country updates.
  • Generate monitoring plan and trip report completion annotations


Education and Experience:
  • Bachelor's degree and previous experience comparable to 5+ years.
  • Monitoring or Study Management, and Oversight experience preferred.
  • Extensive Neuroscience experience preferred.
  • Prior client-dedicated experience preferred.


Knowledge, Skills and Abilities:
  • Advanced mentoring/leadership/supervisory skills
  • Excellent clinical trials monitoring skills; ideally remote AND onsite experience
  • Demonstrated understanding of or ability to learn the company's SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
  • Strong organizational and negotiation skills
  • Strong attention to detail
  • Advanced written and oral communication skills
  • Strong knowledge of English language and grammar
  • Demonstrated use of computer to include data entry, archival and retrieval
  • Ability to travel as needed
  • Excellent team player with team building skills
  • Excellent interpersonal and conflict resolution skills
  • Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
  • Solid knowledge of medical/therapeutic areas and medical terminology


Working Environment:
  • PPD, a part of Thermo Fisher Scientific, values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
  • Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
  • Able to work upright and stationary for typical working hours.
  • Able to work in non-traditional work environments.
  • Able to use and learn standard office equipment and technology with proficiency.
  • Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
  • May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
  • This role requires independent travel up to 20%, inclusive of traveling in automobiles, airplanes, and trains.


Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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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