Pubblicato su stage4eu il: 10/07/2024 Johnson & Johnson, Internship Global Clinical Operations

Johnson & Johnson
Lisboa, Portogallo
Sanitaria/Medicale, Chimica/Farmaceutica, Scienze naturali
12 mesi (da settembre) 
vai all'offerta
Attività:

 

Study Planning Activities

  • Site Identification: Support the local study team in performing country and site feasibility
  • Trial documentation: Support the preparation of study files and of any other document required pre-trial.

Study Start Up Activities / Site start-up

  • Help LTM/SM in ensuring that the current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site.
  • Support the LTM or the SM in ECs and Health Authorities Submissions.
  • Help the SM in obtaining site related trial documents.
  • Support the LTM/SM in collecting and processing as appropriate the IFDF and related documents throughout the trial.
  • Assist the LTM/SM in conducting local investigator meeting or in making arrangements for the investigators participating in an international meeting as applicable
  • Help in the distribution, collection, reviewing, and tracking of regulatory documents, agreements and training documentation.

Study Execution Activities

  • Support LTM/SM in drug distribution process, where applicable.
  • Support LTM/SM in ensuring that during the trial all relevant trial related documentation is provided to investigators and central IEC (if applicable) within the timelines.
  • Support the LTM/SM in maintaining the study files.
  • Provide administrative and logistic support to LTM/SM in tracking of progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence and other relevant tasks as appropriate, where applicable

Study Close Out Activities

  • Site closure: Provide administrative and logistic support to the LTM/SM in activities related to study/site closure, as appropriate, and follow up of all items identified.

General Activities

  • Base all actions on Credo. Protect the rights of others, protect privacy and company assets.
  • Work in line with the HCC, company policies and procedures, including SOPs, having the ethical aspect in mind. Comply with ICH-GCP and all applicable local laws and regulations.
  • Maintain communication with relevant parties within and outside the company
  • Actively follow trainings to ensure adequate qualification
  • Regularly update information in applicable systems and templates
  • Contribute to maintain quality standards and timelines that are consistent with business needs
  • Report every J&J product related complaint you receive to the company, according policies.
Requisiti principali:
  • Degree in Pharmacy, Biology, Biotechnology, Biochemistry or similar.
  • Studying the Master's degree in clinical trial monitoring.
  • English B2-C1.
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