Thermo Fisher Scientific

Start-up Team Manager - FSP

Thermo Fisher Scientific • $100K — $120K *
US-Anywhere
+ 2 other locationsRemote
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in relevant field
  • 5+ years of experience in site start-up within CRO or Pharma
  • Strong knowledge of clinical research phases and terminology
  • Proven ability to manage cross-functional project teams
  • Familiarity with regulatory compliance and activation standards

Responsibilities

  • Collaborate with team for effective site activation across studies
  • Coordinate SSU specialists to ensure alignment
  • Ensure adherence to activation timelines and quality standards
  • Serve as escalation point for regional operational issues
  • Facilitate knowledge sharing among countries within regions
  • Monitor study status and provide risk metrics to leadership
  • Manage technical aspects, including feasibility and EC submissions

Benefits

  • Remote work flexibility within the US or Canada
  • Opportunities for professional development and learning
  • Collaborative team environment
  • Supportive of cross-cultural awareness and adaptability
  • Access to company resources for continued education
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Job Summary

As the Start-up Team Manager (FSP) at Thermo Fisher Scientific, you will play a pivotal role in site activation & manage complex site operations; ensure compliance with regulatory standards. In addition, this individual will be responsible for: supporting site recruitment and training efforts and facilitate smooth collaboration between trial sites and internal teams to drive the success of clinical studies.

This individual is responsible for managing effective delivery of site activation within their assigned region(s). This role involves overseeing site activation according to timelines and quality standards, coordinating with others on a cross functional level, and managing technical and operational aspects.

Role: Start-up Team Manager
Location: Remote, US or Canada
  • Collaborate with team members to ensure effective site activation within assigned studies.
  • Coordinate SSU specialists across regions.
  • Ensure sites within their specific region are on track with the critical path site activation plan.
  • Serve as an escalation point for issues identified by SSU specialists, including regulatory and vendor setup issues.
  • Facilitate knowledge transfer across countries within regions.
  • Work with other Regional/Oversight Leads to resolve issues and ensure activation activities adhere to the agreed plan.
  • Oversee site activation according to timelines and quality standards within their specific region.
  • Assist with information flow between key stakeholders involved in site activation.
  • Oversee EC submission strategy and required documents (e.g., patient material, insurance certificates).
  • Provide quality checks for EC submission packages for both central and local ECs.
  • Manage technical and operational aspects, including feasibility, site selection, contracts coordination, and EC/RA submissions.
  • Ensure operational readiness for site activation in collaboration with CML (e.g., site binders, ancillary supplies, lab kits, training, system access).
  • Monitor regional study status, identify risks, and provide metrics to Study Start-up (SSU) Oversight Lead.
  • Maintain metrics and tracking tools for regional startup activity.
  • Perform risk identification and contingency planning, participate in risk escalation meetings as required, and collaborate with study team to address issues and implement solutions for countries and sites in region.
  • Manage country and site Informed Consent Form (ICF) timelines; review and approve country ICFs.
  • Provide performance feedback to People Manager and support staff learning opportunities.
  • Utilize problem-solving techniques in a changing environment.
  • Prepare for and participate in country level meetings.
  • Oversee and manage the clinical trial insurance local policy country set-up for region.
  • Oversee and manage amendment implementation as needed.

Skills and Abilities:
  • Effective collaboration with cross-functional teams.
  • Knowledge of key principles of cross-functional project management.
  • Strong organizational and multitasking skills.
  • Attention to detail.
  • Ability to identify and mitigate risks related to contractual deliverables.
  • Cross-cultural awareness and adaptability.
  • Comprehensive understanding of clinical research and development, including medical and therapeutic areas, phases, and terminology.
  • Ability to lead, liaise, and coordinate cross-functional project teams.
  • Knowledge of clinical development guidelines and directives.

Education and Experience:
  • Bachelor's Degree
  • Must have previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 5+ years
  • SSU experience has been in: CRO, Pharma organizations, highly preferred
  • In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Physical Requirements:
• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequent mobility required.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

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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