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Clinical Trial Administrator

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a Clinical Trial Administrator who can join an exciting working environment in a dynamic atmosphere.

 

Responsibilities:

  • Participates in the completion of the request for proposal to clinical vendors (CROs) in collaboration with the Clinical Program Managers (CPMs)
  • Manages study related payment procedures
  • Provides input for budget development at Forecast and Preclosing; checks monthly costs invoiced to Company based on planned study activities vs actual; checks monthly the invoices and all the administrative trackers received by the CRO and by the other vendors; manages the Investigator Fees reconciliation and support the CPM in all activities related to budget operations.
  • Manages purchase order in SAP for CRO and for any providers necessary to the trial and is in charge of the management of the Service Entry Sheet (Ses) related to the clinical trial.
  • Supports the CPM in ensuring the compliance of the clinical trial with SOPs and necessary standard.
  • Supports the study team during internal audit and inspections.
  • Handles and maintains paper/electronic TMF and electronic internal repository according to ICH/GCP guidelines and European standards; trainer to CRO for TMF Plan and checklists; responsible for periodic quality checks and for TMF reconciliation after study completion.
  • Interacts with external providers during study conduct (CROs, monitors and, occasionally, with investigators and Hospital personnel)
  • Collaborates with CPM, Trial Supply Unit and QA in order to manage activities related to Clinical Trial Supplies
  • Organizes and/or participates to Kick Off Meetings, Study Design Meetings, and phone-conferences with the CROs for the continuous update on clinical studies. May participate if required to the Investigator's Meetings or to Monitoring Visits
  • Assists the eCTD team in the formatting of all documentation related to a clinical study, aimed at obtaining an electronic copy of the registration dossier.
  • Review and management of CROs contract; prepares draft contracts far consultants/ providers and interact with legal department
  • Prepares and maintain all trackers far the study conduction, management of the study

 

Profilo

 Requirements and skills:

  • High School and/or College Degree
  • Various Certifications which attest familiarity with relevant ICH/GCP and SOPs.
  • Time management
  • English knowledge

 

 Type of contract: Temporary contract

 

 

IQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 –) to IQVIA and to transfer those data to IQVIA’s Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).

8 novembre 2022
Azienda
IQVIA
Categoria
Amministrazione
Località
Italia
Tipologia contrattuale
Full Time
Lingue richieste
inglese
Livello lingua
good
posizione chiusa
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