Eap Coordinator - Paris e, France - Cmed
Description
The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies.
Our offices are located in France, Belgium, Switzerland, Germany, Denmark, Sweden, UK, Romania, US, India and Czech Republic.
The CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own technologies for managing clinical data.
This is a very exciting time to join as we are at the cutting edge, defining new and more efficient ways to design, capture, manage, review, and visualize clinical trial data.
We are currently looking for an enthusiastic and talented EAP Coordinator / CTA. This role can be partially remote and must reside in France.QUALIFICATION:
Within the Clinical & Regulatory department, the AP & CPC Administrator is responsible for the implementation and conduct of activities related to the early access programs and compassionate prescription framework known as AP or CPC for which they are responsible in compliance with medical ethics, and the regulations in force.
The AP programmes concern medicinal products which do not have the Marketing Authorisation (AMM) or are awaiting publication in the Official Journal but whose efficacy and safety of use are strongly presumed.
The AP/CPC administrator is in charge of patient data management as part of the AP/CPC of the products under development.
The main role thus focuses on:
Data entry operations.
The operations of the reminder of the prescribers and priority the operations of data entry resulting from the reminder of the prescribers.
The maintenance of any necessary contact with health professionals (doctors, pharmacists), in particular with regard to the proper maintenance of the database and/or in response to specific requests from these professionals and falling within the scope of responsibility of the service
Collect, record and transmit information or requests to internal or external entities
Main responsibilities
Roles and responsibilities are related to the activities described above:
Compliance of Request for Authorization for Processing/Entry of Patient Data:
Quality control of the data entered
Checking for missing data
Review of discrepancies
Revive health professionals to obtain patient follow-ups.
Enter data related to PA and CPC monitoring: management of monitoring sheets and maintenance of the quality and consistency of databases.
Support for activities related to AP and CPC:
Carry out the pharmaceutical validation of orders (under the authority of the responsible pharmacist) and transmit them according to the defined procedures.
Record and archive documents and tracking sheets received according to the procedures in place.Answer questions related to patient follow-up and orders
Follow the evolution of the related FAQ
Point of contact for healthcare professionals:
Collect, record, transmit and track the transmission of information related to pharmacovigilance and quality complaints.
Management of Product Requests:
Receipt, verification and handling of inconsistencies on product requests
Compliance of the purchase order
Ancillary administrative tasks:
Aftercare:
Ensure pharmacovigilance requirements compliance with the requirements for monitoring Adverse Events (AEs).
In charge of the toll-free number (incoming call and tracking of actions in the tracking table).
In charge of the generic mailbox of the AP/CPC.
Manage all Requests for Additional Information related to DAT sheets;
Ensure the entry of paper cards received
Required qualities and skills
Autonomy, rigor and organization
Good communication skills
Ability to work in a team in a flexible and reactive way
Knowledge of the Regulations applicable in his/her field(s) of activity
Computer knowledge
eCRF
e-data (module Biometry assistant / Data entry operator),
Office software:
Word, Excel, Adobe Acrobat Professional, Outlook
Languages
French:
Fluent
English:
Common practice of technical and common vocabulary for written comprehension and communication.
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