Thermo Fisher Scientific

Global Study Lead - FSP Team

Thermo Fisher Scientific • $120K — $150K *
US-AnywhereRemote in North Carolina, US
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted Yesterday
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in life sciences or related discipline.
  • 5-7 years of experience in clinical research and project management.
  • Proven experience leading global study teams in pharmaceutical or CRO environments.
  • In-depth knowledge of ICH/GCP guidelines and regulatory processes.
  • Strong leadership, influencing, and negotiation skills.

Responsibilities

  • Lead the strategic planning and operational delivery of clinical studies from initiation to archiving.
  • Oversee compliance with regulatory guidelines and company SOPs for studies.
  • Facilitate effective communication with stakeholders regarding study status and risks.
  • Support Working Groups in identifying and mitigating study risks effectively.
  • Accountable for the overall study budget and financial reviews.

Benefits

  • Collaborative work environment with opportunities for innovation.
  • Exposure to cutting-edge technology in clinical trials.
  • Empowerment within a matrix team structure to drive decisions.
  • Opportunity to lead major clinical studies impacting global health.
  • Support for professional development and growth within the organization.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Job Title: Global Study Lead (GSL) Department: Global Clinical Study Delivery (GCSD), Global Clinical Operations

Job Purpose:

This position within GCSD is accountable for leading the operational strategy, planning and delivery of the study/studies end to end from CSI (Commit to Study Initiation) until study archiving to time, quality, budget, company standards and scientific requirements as outlined in the clinical development plan. The GSL owns the vision for study success, the prioritization of deliverables and formation of Working Groups with key leadership across the matrix organization with the Study Level Statistician and Clinical Lead. The GSL represents Clinical Operations within the Study Leadership Team (SLT).

Key responsibilities include, but are not limited to:
  • GSL will be a member of the Study Leadership Team (SLT) with accountability for the strategic leadership and delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, driving decision making at pace and strategically leading study team to achieve overall study deliverables.
  • Provide oversight and support (where needed) to the GSM and SM (as appropriate) on end-to-end clinical study delivery. Serves as the point of escalation for Clinical Operations.
  • Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies. understand study contribution to program/submission
  • Accountable for translating asset requirements to the study and appropriate communication with the Clinical Operations Asset Lead.
  • Balance risk/benefit to make decisions based on clear understanding of impact on the study and project.
  • As the SLT escalation point for clinical operations, support the Working Groups leads to proactively and effectively identify, oversee, and mitigate study risks.
  • Ensure appropriate stakeholder communication, including study status, expectations, risks and issues.
  • Ensure robustness in upfront feasibility and planning.
  • Preparation of materials for governance and / or financial review cycles.
  • Accountable for the study budget.
  • Effectively build and lead empowered matrix teams.
  • Implement innovative approaches to study delivery through external facing advances in technology and sciences and encourage others within matrix and line teams to seek innovative perspectives and develop solutions in collaboration with the GSM and SM.
  • Decision maker for the innovative solutions (e.g. DCT) to be used at study level.
  • Provide strategic oversight on operational input into protocol and informed consent form development, and other key study documents.
  • Ambassadors in increasing utilisation of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working.
  • Oversee quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.
  • Lead / contribute to ways of working and process improvement initiatives.
  • Provides therapeutic area expertise to support operations.
  • Escalation point for vendor issues.
  • Leads assessment and selection of FSO vendors in collaboration with COAL.
  • Accountable for holistic oversight of FSO vendors according to the FSO handbook in collaboration with GSM and SM.
  • Accountable for assessment and selection of other study vendors under GCSD responsibility in collaboration with GSM and SM.


Education Requirements (minimum expected):

Bachelor's degree: life sciences or related discipline The role will require a good understanding of complex clinical development and regulatory processes.

Job Related Experience (minimum requirements):

Highly experienced strategic leader capable of performing study accountable role in an autonomous way across multiple studies or a single large / complex study. Has depth and breadth of experience in clinical delivery, across indications, assets, phases, regions, etc. This level of experience is required to provide clinical trials and project management expertise as well as adequate leadership.

Other Job-Related Skills:
  • Extensive clinical development experience and proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.
  • Proven operational experience of leading high performing global study teams in clinical trials. Able to drive decision-making at pace and strategically lead study team in an autonomous way to achieve overall study deliverables in complex and high pressure environments.
  • Ability to influence and manage stakeholders at senior director and/or VP level.
  • Ability to translate strategic concepts, stakeholder feedback and requirements into cohesive actions for the study team.
  • Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget.
  • Excellent leadership skills, influencing and negotiation skills.
  • Demonstrated experience leading in the matrix environment to drive decisions, deliver projects, develop clinical plans and manage change.
  • In-depth knowledge of study management and knowledge of essential global regulatory guidelines and ICH/GCP.
  • Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations and third-party vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned.
  • Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.
  • Excellent project management skills and budget management skills.
  • In-depth experience in strategic leadership of innovative trial design including (but not limited to) adaptive designs and decentralised trials (DCT) design, with the learning agility to lead other/more complex innovative trial designs such as platform/umbrella/basket.
  • Highly developed communication skills appropriate to the target audience, promoting effective decision making where necessary and ability to manage conflict.
  • Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting crossfunctional matrix teams.
  • Creative thinker able to modernize approach to clinical delivery, leverage external technology and networks to deliver value.
  • Ability to articulate and champion key decisions and strategy.
  • Ability to define value-driven vision and roadmap for the study.
  • Ability to effectively prioritize activities and stakeholder needs.
  • Makes timely and complex decisions based on strong rationale.
  • Very strong TA experience; where possible consolidated to specific areas / indications.
  • Growth Mindset and Mental Agility: Ability to work across various therapeutic areas and manage different types of studies effectively.
  • Ability to connect people with our purpose.
  • Ability to create psychological safety.
  • Ability to foster collaboration and to empower others.

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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