France 17.03.2023

Clinical Research Director MD M/F

AIXIAL a French CRO ...

Tasks

Aixial Group, CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market.

 

Since 2014, we have been part of the Alten family. We are developing our activities in France, Belgium, Germany, Czech Republic, Denmark, UK, US...with even more prospects for expanding internationally.

We continue to grow, integrating Larix and CMED into our activities.

 

Aixial Group, operates in outsouring, insourcing, for pharmaceutical, cosmetic, medical device, biotechnology, nutrition,... activities in clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, HEOR...

 

Aixial Group continues to grow, and to recruit in the clinical trial professions. Come and join us, and discover our site to follow the news of our offers.

 

Aixial Group is looking for a MD Clinical Research Director M/F, remote in Europe, with more 3 years of experience.

Requirements

You will contribute to all complex study related activities from set up to closure :

  • Contribution to the documents elaboration relating to the trials: abbreviated protocol, protocol, informed consent (ICF), protocol and ICF amendments, medical data validation plans, answers to medical questions, contribution to various meetings (investigators, monitors, etc.), management of study committees’ preparation.
  • Medical review of data on patient profiles, listings and CIOMs.
  • Close collaboration with Trial Operations (TO), pharmacovigilance (CME / GSO) and statistics for the establishment of the listings necessary for the review of data consistency.
  • Review of study related documents: CRF, CRF completion instructions, deviations list, validation plan, protocol review form, ...
  • Contribution to the review of interim and final studies reports, associated statistical tables and draft publications.
  • Medical review of files, reviews of medical listings and contribution to the management of clinical studies (writing of protocols, basic clinical analysis, study set-up, medical training, medical responses) in the field of studies, regardless of the type of study.
  • Medical review and Guidelines to be written for medical reviews in the context of outsourcing or whenever applicable
  • Working language and document writing in English

 Your profile

  • You validated a MD in Clinical Operation training or scientist ...
  • You have 3 years or more experience in clinical study field
  • You have a full professionnal english level
  • Available in short/middle time - and able to work in Europe
Apply
Copyright © www.aixial.com - All Rights Reserved - Legal disclaimer
SPONTANEOUS APPLICATION
close

SPONTANEOUS APPLICATION








    AIXIAL informs you that the data we have gathered in this form is indispensable to manage the recruitment process involving the computer processing of your personal data. The collected data may be forwarded to the Group's various entities for the same purposes.
    We remind you that you have a right of access, correction and deletion for the data relating to you, a right of limitation, portability, erasure and opposition for legitimate reasons that you may exercise by sending an email to our DPO at the following address : dpo-france@aixial.com.
    Your personal data is intended for the authorized departments of AIXIAL and it will be retained for a period of 2 years as from our final contact.
    For further details, please consult the AIXIAL Privacy Policy : Data protection policy