Trial Activation Specialist II
2 semanas atrás
**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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