Senior Feasibility Site Specialist

Thermo Fisher Scientific · Remote

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Job Description

Sr Feasibility Site Specialist

Job Description

Join Us as a Sr Feasibility Site Specialist - Make an Impact at the Forefront of Innovation

The Sr Feasibility Site Specialist develops the critical path for site activation within assigned projects to provide consultation, guidance and support for rapid site activations.

Purpose:

Represents Thermo Fisher Scientific in the global medical research community and is the main point of contact for potential investigative sites. Provides strategic review in feasibility planning and execution and ensures sites receive support and issue resolution throughout the feasibility process. Using local knowledge, company systems, external sources and sponsor input, create, reviews and recommends site lists and conducts pre-award outreach suitable for study needs. Serves as a subject matter expert to cross-functional teams, mentors junior team members and contributes to continuous process improvement initiatives.

Performs administrative and analytical tasks supporting the investigator database, site identification, site list development and rapid site start-up deliverables. Create, reviews, validates, and recommends site lists in applicable clinical systems and performs quality control and risk monitoring to mitigate risk and support data quality in local and global investigator databases. Depending on business needs, regional operating models and organizational requirements, the Senior Feasibility Site Specialist may perform different combinations of these responsibilities while contributing to feasibility objectives. Reports to Clinical Operations People Manager.

Major Job Responsibilities

• Gathers feasibility data and performs local site list vetting and pre-award site outreach, using approved internal tools and external sources to ensure the site list is specific to the assigned study indication.
• When acting as Global Feasibility Coordinator, validate the initial draft potential site list created by country FSS teams, by reviewing approved data in collaboration with feasibility managers, project and local teams for assigned studies or customers; ensures agreed Service Level Agreement timelines and metrics are met across the specified region or regions. Appointment as coordinator depends on utilization capacity and the skills required to coordinate global data.
• Uses site-profile data and execution outcomes and provides analysis on site suitability, country strategy, risk, capacity, start-up assumptions, bid-defense and pre-award phases. May administer, prioritize and resource the site-list development and list-loading process and collaborate with other departments to support rapid site start-up.
• Ensures site and database contact and account information is current. Liaises with other departments, including Legal and Quality, to manage investigators with medical-license concerns or disciplinary actions, FDA or Regulatory restrictions, ISD disclosures, privacy issues and quality-of-performance concerns; ensures regulatory processes and due-diligence checks are conducted, documented, filed and escalated as necessary in an expedited manner.
• Reviews Confidential Disclosure Agreements (CDAs) and site survey data for accuracy, completeness and consistency; follows up with investigative sites to resolve discrepancies or missing information. Coordinates and manages feasibility site-document collection and tracking to support study milestones and deliverables, ensuring timely completion, data accuracy and adherence to quality and compliance requirements.
• May conduct phone interviews with physicians and other site personnel to discuss standard of care and obtain protocol-level input; where applicable, conducts onsite feasibility visits.
• May support or participate in client calls and address study-specific client requirements related to site-feasibility communications at the direction of functional leadership or the People Manager. Develops local intelligence and acts as a local expert regarding site capacity and expertise; works with key personnel to gather knowledge and recommend additional sites. Collaborates with study and country stakeholders, including Country Heads, Start-up Managers, Clinical Leads, CRAs/site-facing roles and Clinical Operations People Managers, on assigned studies.
• Contributes country/site intelligence to RFPs, bid defenses, early TBU discussions and protocol reviews; translates site data into recommendations on suitability, strategy, risk, capacity and start-up assumptions; and updates site profiles using execution outcomes, performance, quality signals, start-up timelines and relationship insights, as applicable.
• Participates in regional/country team meetings and proactively contributes best practices and lessons learned.
• Partners with Country Heads, CRAs/site-facing roles and Clinical Leads to validate local realities and share any study/operational updates/risks.
• Mentors and develops FSS team members; leads training sessions and contributes to development initiatives, as applicable; serves as a subject matter expert for therapeutic indications and the therapeutic landscape.
• Drives implementation of new feasibility processes and digital tools at regional/global level and contributes to the design, validation and optimization of electronic feasibility tools and survey platforms.
• Identifies process gaps and leads continuous-improvement initiatives; identifies risks to quality/compliance and develops mitigation plans. Adheres to assigned goals and performance objectives and completes required training and compliance activities within established timelines.
• Establishes and maintains collaborative relationships with investigative sites and site networks to facilitate study start-up, site engagement and ongoing site support.

Qualifications:

Education and Experience:

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification.
• Previous feasibility and clinical research experience that provides the knowledge, skills and abilities to perform the job (2–5 years).
• Previous experience as CRA or in a site-facing position is preferred.
• In some cases, an equivalency consisting of appropriate education, training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role. 

Knowledge, Skills, and Abilities:

• Effective oral and written communication skills, including medical terminology.
• Excellent interpersonal skills.
• Strong attention to detail and quality of documentation.
• Good negotiation skills.
• Good computer skills (Microsoft Office) and the ability to learn appropriate software.
• Fluency in the local language, as well as a good command of the English language and grammar skills.
• Ability to work in a team or matrix environment, or independently, under direction.
• Basic organizational and planning skills.
• Ability to attain and maintain a working knowledge of GCP and applicable SOPs.
• Proven flexibility and adaptability.
• Ability to manage risk and perform risk escalation appropriately.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

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