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Regulatory Start Up Specialist - CRO

Business Type: Clinical Research Organisation, Contract Research Organisation, Pharmaceutical Services
Job Type: Clinical Research, Clinical Operations, Clinical Study- Trials, Regulatory Affairs
Job Level: Entry Level
Position: Full Time
Location: Italy
Reference: PC.67685.3
Closing Date: 27/04/21
Job Details:

For an important and established Italian CRO, which provides services and expertise to the Pharma and Medical Device industries, with over than 40 years of experience, specialized in clinical development, managing multinational pre-registration clinical trials (Phases I, II, III), post marketing clinical trials (Phase IV), as well as epidemiological studies, observational studies and outcome studies, in both East Europe & West Europe, I am currently looking for a Regulatory Start Up Specialist with at least 1 year of experience in the role.

What will you do:

  • Cooperation and support the Start Up Unit Specialist on the activities needed to obtain the Competent Authority and ethical authorizations relevant to the assigned Clinical Trials according to GCP, applicable regulatory requirements and Sponsor''s SOPs;
  • Obtaining information and documents from Ethics Committees (Member list, EC regulation/Procedures, templates and forms, meeting minutes, etc.);
  • Management and updating of Start Up Unit archive;
  • Management of study material shipment and retrieval and monitoring of materials specific for Start-Up Unit functioning;
  • prepare periodical study reports to be provided to the Sponsor;
  • work in liaison with the Sponsor''s Clinical Operation Manager responsible for the assigned clinical trial, under the supervision of the Start Up Unit Specialist and HCO, granting an appropriate performance of activities and updating on the authorization status progress;
  • preparation of the Investigator''s File.

Who am I looking for:

  • Scientific Degree.
  • Previous experience in the Start Up Unit (Pharmaceutical Industry or CRO).
  • Good stress resistance.
  • Good organization capabilities in order to manage effectively the approval of multicenter trial in a short time.
  • Knowledge of regulatory requirements and ICH GCP.
  • Good knowledge of computers tools.
  • Written and Spoken English.

If you want to know more about this opportunity submit NOW your CV to Patrick Carignano -

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. We have a strong presence within Italy as well as Germany, Switzerland, France, The Nordics and Benelux. Please visit our website for a full list of the niche markets we cover.

NonStop Consulting Limited Posted by:: NonStop Consulting Limited (View all our vacancies)
Unless otherwise stated, if applying for a job, you must ensure that you are already authorised to work in the country in which the job is based
Posted: 20/04/2021 | NPJ Ref: 269319
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