Clinical Research Director MD M/F
AIXIAL a French CRO ...
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.
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
- 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