Trial Activation Specialist II

2 semanas atrás


São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

**About Thermo Fisher Scientific**

We are a leading global contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services.

**Our Mission**

We are passionate, deliberate, and driven by our purpose to improve health.

**Our Team**

We are the people of Thermo Fisher Scientific clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.

**Our Culture**

We are a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

**Our Work**

We partner with our sites, businesses, and colleagues around the world to decrease startup timelines and exceed expectations.

**Key Responsibilities**

As a **Country Approval Specialist**, you will be responsible for pulling regulatory Country Submissions together in order to activate investigative sites.

**Your Key Tasks**

• Provide local regulatory strategy advice to internal clients

• Provide project-specific local SIA services and coordination of these projects

• May have contact with investigators for submission-related activities

• Key-contact at country level for either Ethical or Regulatory submission-related activities

• Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines

• Achieve PPD's target cycle times for site activation

• May work with the start-up CRA(s) to prepare the regulatory compliance review packages

• May develop country-specific Patient Information Sheet/Informed Consent form documents

• Enter and maintain trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner

• Ensure the local country study files and filing processes are prepared, set up, and maintained as per PPD WPDs or applicable client SOPs

• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided



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