Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
When you join the team at Thermo Fisher Scientific, you will do meaningful work that makes a positive impact on a global scale. Join 130,000 colleagues who bring our mission to life every single day, to enable our customers to make the world healthier, cleaner, and safer.
The PPD™ clinical research business of Thermo Fisher Scientific is a leading provider of global Clinical Research solutions. We provide clinical drug development, laboratory services and lifecycle services to pharmaceutical, biotechnology, medical device, academic and government customers. By harnessing innovative technology and expertise, we work to empower our customers to bring therapies to market faster.
The Sr. Feasibility Site Specialist (SFSS) represents Thermo Fisher Scientific in the global medical research community and is the main point of contact for potential investigative sites. This role provides strategic review in feasibility planning and execution and ensures sites receive support and issue resolution through the feasibility process. Using local knowledge, company systems, external sources and sponsor input, the SFSS will review and recommend site lists and conduct pre-award outreaches, that are suitable for the needs of the study. Reports into the Feasibility People Manager. The SFSS will serve as a subject matter expert to cross-functional teams while mentoring junior team members and contributing to continuous process improvement initiatives.
Essential Functions:
- Gathers feasibility data and performs local site list vetting, Pre-award site outreaches, using approved internal tools and external sources to ensure the site list is specific to assigned study indication)
- Reviews Confidential Disclosure Agreements (CDAs) and site survey data to ensure accuracy, completeness, and consistency, and 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
- Ensures site and database contact information is current and accurately documents all communication attempts with sites.
- May conduct phone interviews with physicians and other site personnel to discuss standard of care and obtain protocol-level input.
- Where applicable, conduct onsite feasibility visits
- May support or participate in client calls and address specific client requirements related to site feasibility communications, as required for the study and at the direction of functional leadership or the People Manager (PeM)
- Maintains required knowledge of and ongoing compliance with all applicable systems, tools and procedures
- Participates in Regional/country team meeting and proactively contributes on best practices and lesson learnt
- Mentors and develops FSS team members
- Leads training sessions and contributes to development initiatives, as applicable
- Serves as subject matter expert (SME) for therapeutic indications/landscape
- Drives implementation of new feasibility processes and digital tools at regional/global level
- Contributes to the design, validation, and optimization of electronic feasibility tools and survey platforms
- Identifies process gaps and leads to continuous improvement initiatives
- Identifies risks to quality/compliance and develops mitigation plans .
- Establishes and maintains collaborative relationships with investigative sites and site networks to facilitate study start-up, site engagement, and ongoing site support
- 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 team stakeholders' example, local clinical operations, Country Head, Startup manager and Feasibility Manager (FM) on assigned studies.
- Adheres to assigned goals and performance objectives and completes all required training and compliance activities within established timelines
Education and Experience:
- Bachelor’s degree or equivalent and relevant formal academic / vocational qualification.
- Previous feasibility and clinical research experience which provides the knowledge, skills, and abilities to perform the job (2-5 years)
- Previous experience in 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, 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 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
PPD values the health and well-being 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.
- Ability 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 require as-needed travel (0-20%).
