Country Approval Specialist (Buenos Aires)

Country Approval Specialist (Buenos Aires)

06 ago
|
Thermo Fisher Scientific
|
Buenos Aires

06 ago

Thermo Fisher Scientific

Buenos Aires

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 integral 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 combinatio...

📌 Country Approval Specialist (Buenos Aires)
🏢 Thermo Fisher Scientific
📍 Buenos Aires

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