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Clin Trials Admin (6 Months) Full-time

de Covance Lisboa em Lisboa (Publicado em 02-03-2021)

Job Overview:


New Covance job open: Clinical Trial Assistant, CTA. Sponsor dedicated, office based Lisbon.
This is a temporary position (6 months) at Covance, office based (Oeiras district), and will be working sponsor dedicated with a large Pharmaceutical company in cutting edge Therapeutic areas like Oncology, Cardiology or Diabetes.
We need you to have some experience either at a CRO, Sponsor or Clinical Trials Hospital Unit, in the following areas:
Submissions

  • You will be the preferential contact person with both Health Authorities & Central Ethics Committee to ensure appropriate follow-up of all submitted Clinical Trials and obtain the corresponding authorizations.

  • You will coordinate with local Monitoring Teams: the preparation of the CTA documentation to ensure its submission according to established timelines and the preparation of responses to clarifications requested by Health Authorities or Central Ethics Committee.

  • Notify both Health Authorities & Central Ethics Committee any relevant information related to Clinical Trials (e.g. amendments, end of trial, etc.).

  • Coordinate submissions to National Data Protection Committee.

Contract management

  • Be the preferential contact person with the Administration Boards for contract negotiation and management.

  • You will establish master agreements with key 1 hospitals in order to speed-up the contract negotiation.

Harmonization of several transversal activities
:
We will trust you to organize central filing of common regulatory documentation (CVs, GCP training, Data Privacy, Lab. Ranges, Etc.)


Education/Qualifications:


Experience:


You bring some CTA or Study Nurse or Study Coordinator experience working at a CRO, Sponsor or Clinical Trials Hospital Unit, ideally in international ph I-IV clinical trials.
Excellent Portuguese and English language is required, both spoken and written.
Your aptitude for handling and proofreading numerical data and your spreadsheet software competency will be essential to avoid delays and issues during the course of the project


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