Senior Clinical Trial Administrator

Date:  3 Feb 2024
Department:  Global Clinical Development
Team:  R&D, Pharmacovigilance & Regulatory Affairs
Job Type:  Direct Employee
Contract Type:  Permanent
Location: 

Parma/Paris/Blois, FR

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management.  Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden) and Toronto (Canada).

 

Who we are looking for

Purpose

To manage the administrative aspects of clinical trials at every stage of the process (study documents, implementing and maintaining databases, coordinating payments and supplies to research units.)

Main Responsibilities

•    Study documentation and Trial Master File
-    Prepares/assembles study documentation, including but not limited to submission package for Regulatory Authorities and Ethics Committees, study documents prepared through Chiesi’s EDMS (HERMES), reviews English texts and translations and is responsible for formatting study documents, such as study protocols, clinical study reports, etc.
-    Follows the process in place for the publication of an article related to a clinical study, when required.
-    For studies performed under IND, CTA is responsible for assembling relevant documentation for submission
-    Requests ad-hoc study insurance policies and ensures the maintenance during the entire study lifecycle.
-    Responsible for electronic TMF set-up and maintenance during the study (DIA Ref. Model, 11 Zones), oversees the completeness of documentation filing, through ongoing health reports, quality reviews and verification of metrics’ status with the support of Chiesi’s eTMF vendor, oversight of CRO filing activities in the eTMF
-    Responsible for eTMF and paper TMF reconciliation after study completion

•    CRO Cost and Payment Process
-    Participates in the review of Request for Proposals sent to CROs in collaboration with the CPMs, especially for the section related to eTMF.
-    May be asked to follow the CRO Awarding Process and may prepare the necessary procedure in SAP for the payment of monthly invoices. If required, CTA also follows study purchase process in SAP according to Chiesi policies.
-    Collaborates with the CPM for budget development at Forecast, Preclosing; checks monthly costs invoiced to Chiesi based on planned study activities vs actuals through our dedicated tool (TTP) and ensures that invoices received are in line with all that is indicated in the TTP; assists the CPM in the reconciliation of Investigator Fees and supports her / him in all activities related to budget operations.
-    Supports CPM in trial disclosure reports, both internally and externally to the company, (eg.  Investigator Fees disclosure.

•    CPM support and CRO oversight
-    Organizes and participates in Kick Off Meetings, Study Design Meetings, and regular phone-conferences with the CROs for the continuous update on clinical studies. May participate, if required, to the Investigator’s Meetings and other study specific meetings.
-    Supports CPM in CRO oversight to ensure that the trial complies with SOPs and all necessary quality standards (ICH/GCP and applicable regulations).
-    Collaborates with the CPM with corrective and preventive actions, in case of deviations and audits.
-    Reviews SOPs, when required.
-    Collaborates with CPM and CTS Unit for the preparation of CTS request forms.
-    Manages the maintenance of CT.gov through the appropriate system

•    CSR and eCTD support 
-    Manages the approval process of the Clinical Study Report in our EDMS (Hermes) and is responsible for the formatting of the document and its related appendices.
-    Assists the eCTD team with the formatting of all documentation related to a clinical study, aimed at obtaining an electronic copy of the registration dossier.
 

Experience Required

At least 2-3 years of experience in similar role within pharmaceutical company or CRO.

Education

High School and/or College Degree (preference scientific background or accounting)

Nice to have: Certifications which attest  familiarity with relevant ICH/GCP  EU and FDA Guidelines and SOPs

Languages

Good knowledge of English both written and spoken

Technical Skills

  • Knowledge of ICH/GCP  EU and FDA Guidelines and SOPs
  • Knowledge of Excel for budget purposes
  • Knowledge of eTMF and Clinical Study Report (CSR)
  • Familiarity with electronic Data Management Systems 
  • Nice to have: experience with CT.gov

Soft Skills

  • Attention to details
  • Planning and organizational skills
  • Problem solving
  • Stress management
  • Team working
  • Time management

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.

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