Eap Administrator

AIXIAL 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 and Czech Republic.

Through Cmed (a part of the Aixial Group), the CRO occupies a unique position in the clinical research industry, not only as an expert in the operational delivery of clinical trials for immuno-oncology and cell & gene therapies, but also as a developer of its own technologies for managing clinical data.

**QUALIFICATION**:
Within the Data Management 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 CPC programmes provide a framework for requirements that do not comply with the AMM,

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.

Follow-up of patients.

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.