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Trial Activation Approval Specialist Ii
3 meses atrás
PPD, now Thermo Fisher's clinical research business, is a leading global contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services.
**At PPD, we are passionate, deliberate, and driven by our purpose
- to improve health**We are vital links between an idea for a new medicine and the people who need it.
We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose:
to improve health.
You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Our dedicated teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations.
As a
Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites.
You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.
Key responsibilities:
- Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients
- Provides project specific local SIA services and coordination of these projects
- May have contact with investigators for submission related activities
- Keycontact at country level for either Ethical or Regulatory submissionrelated activities
- Coordinates, under guidance, with internal functional departments to ensure various site startup activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation
- Achieves PPD's target cycle times for site
- May work with the startup CRA(s) to prepare the regulatory compliance review packages
- May develop country specific Patient Information Sheet/Informed Consent form documents
- Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner
- Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs
- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
