Job is client office-based in Courbevoie (Paris Area)

The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities
from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and
consistency of interventional study deliverables to time, cost and quality objectives.

CSAs might have different internal titles based on the experience level (CSA, Senior CSA). The experience
level depends on the years of experience, performance record, level of independence in the role, ability to
take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this
internal title after confirmation with Senior Director, Cluster Head / Executive Director, Regional Head.

•Assists in coordination and administration of clinical studies from the start-up to execution and closeout.
•Collects, assists in preparation, reviews and tracks documents for the application process. Assists in
timely submission of proper application/documents to EC/IRB and, where appropriate to Regulatory
Authorities for the duration of the study.
•Interfaces with Investigators, external service providers and CRAs during the document collection
process to support effective delivery of a study and its documents.
•Serves as local administrative main contact and works closely with the CRAs and/or the LSAD for the
duration of the study.
•Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including
document tracking in accordance with ICH-GCP and local requirements.
•Ensures essential documents under their responsibility are uploaded in a timely manner to maintain
the eTMF “Inspection Readiness”.
•Ensures that all study documents are ready for final archiving and completion of local part of the eTMF
and supports the CRA in the close out activities for the ISF.
•Contributes to the production and maintenance of study documents, ensuring template and version
compliance.
•Creates and/or imports clinical-regulatory documents into the Global Electronic Management System
(e.g. ANGEL) ensuring compliance with the client Authoring Guide for Regulatory Documents.

•Contributes to electronic applications/submissions by handling clinical-regulatory documents
according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting
effective publishing and delivery to regulatory authorities.

• Sets-up, populates and accurately maintains information in the client tracking and communication
tools (e.g. CTMS such as VCV, SharePoint, etc) and supports others in the usage of these systems (with
the exception of countries where there is a specific role dedicated to set up and update the systems).
• Prepares and/or supports contract preparation at a site level (with the exception of countries where
there is a specific role dedicated to preparing site contracts).
• Prepares/supports/performs Health Care Organisations (HCO)/Health Care Professionals (HCP)
payments in accordance with local regulations.
• Manages and contributes to coordination and tracking of study materials and equipment.
• Coordinates administrative tasks during the study process, audits and regulatory inspections,
according to company policies and SOPs.
• Leads the practical arrangements and contributes to the preparation of internal and external meetings
e.g., study team meetings, Monitors’ meetings, Investigators’ meetings. Liaises with internal and
external participants and/or vendors, in line with international and local codes.
• Prepares, contributes to and distributes presentation material for meetings, newsletters and websites.

Responsible for layout and language control, copying and distribution of documents. Supports with
local translation and spell checks in English to/from local language, as required.
• Responsible for printing and distribution of documents such as letters and meeting minutes, and for
handling and archiving of study/country related e-mails.
• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions
representatives to facilitate the delivery of study related documents/material.
• Ensures compliance with the client’s Code of Ethics and company policies and procedures relating
to people, finance, technology, security and SHE (Safety, Health and Environment).
• Ensures compliance with local, national and regional legislation, as applicable.

Additional country-specific tasks might be added depending on local needs.

Essential:

•High school/Secondary school qualifications (*),
that supports skills and capabilities of the position
and ensures successful conduct of responsibilities
and appropriate interactions with internal and or
external customers.

•Previous administrative experience preferably in
the medical/ life science field.

•Proven organizational and administrative skills.

•Computer proficiency.

•Good knowledge of spoken and written English.

Desirable:

•Further studies in administration and/or in
life science field are desirable (*)

Working knowledge of the Clinical Study

•Process and an understanding of the range of
working procedures relating to it, together
with an understanding of the ICH-GCP
guidelines.

•Ability to develop advanced computer skills
to increase efficiency in daily tasks.

Good verbal and written communication.

•Good interpersonal skills and ability to work
in an international team environment.

•Willingness and ability to train others on
study administration procedures

•Excellent organization and time management

skills, excellent attention to detail, and ability
to multi-task in a high-volume environment
with shifting priorities.

•Team oriented and flexible; ability to
respond quickly to shifting demands and
opportunities.

•Integrity and high ethical standards.