Country Approval Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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

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


What You'll Do:
• Achieve established project target cycle times for site activations.
• Provide technical expertise on projects on collaboration with relevant internal departments.
• Assist in negotiation and finalizing site agreements, budgets and essential documents with study sites in accordance with local/accepted process.
• Ensure compliance to established negotiation parameters, authority approval, contractual process and client expectations as developed and approved.
• Maintain knowledge of and understand SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Prepare the regulatory compliance review packages, as applicable.
• Liaise within locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
• Develop country specific documents.
• Coordinate with internal functional departments, as needed, to ensure site startup activities within the site activation critical path are aligned.
• Ensure that trial status information relating to activities are accurately maintained in the database and is current at all times.
• May act as the country subject matter expert for site activation and provide local advice as appropriate regarding activation strategy.


Education & Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience.

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.

Knowledge, Skills, Abilities:
• Effective oral and written communication skills
• Excellent interpersonal skills
• Ability to apply strong attention to detail and produce quality of documentation
• Good negotiation skills
• Good computer skills and the ability to learn appropriate software
• Good English language and grammar skills
• Good judgment and decision-making skills
• Basic medical/therapeutic area and medical terminology knowledge
• Excellent team player with teambuilding skills
• Good organizational and planning skills
• Ability to accurately follow project work instructions

Working Conditions and Environment:
• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.

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.