Cdi - Clinical Trial Administration Specialist F/m

il y a 11 heures

Lyon, France bioMérieux sa Temps plein

A family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

**What are your main accountabilities ?**

We are seeking a Clinical Trial Administration Specialist to join our bioMérieux Clinical Affairs team. In a corporate department, you will work with a global team of about 30 Clinical Scientists located in France and in the USA.

This position is necessarily based in Marcy l’Etoile site.

As Clinical Trial Administration Specialist, you will assist and support the conduct of clinical trials related administrative activities as per clinical project timelines. You will act as a liaison person between external Clinical Trial sites, Clinical Scientists and other internal departments.
- Assist in trial Confidential Disclosure Agreements and Agreements preparation with bioMérieux Legal department and the external clinical trial sites,
- Prepare templates for budget estimates and facilitates communication between internal and external partners during contract and budget phases of the Clinical Trial project,
- Manage the clinical sites/external providers referencing, purchase orders, invoicing processes, regular accruals,
- Prepare the documentation package for the purpose of the submission to Independent Ethic Committee or Independent Review Board, as per respective expectations,
- Report any clinical trial related relevant information to competent authorities (e.g. Sunshine act...),
- Maintain the clinical trial related documentation ahead, during and after the completion of the clinical trial, collaboratively with the Clinical Scientist, along with the clinical sites,
- Prepare the on-site documentation as per Good Clinical Practices (Investigator Study File - ISF),
- Structure, prepare and regularly feed the electronic clinical trial master file, including all the trial documentation and main project deliverables.

**What is your profile?**
- BAC+2 level or equivalent required, plus 3-5 years in the industry, ideally with a clinical research background
- Excellent oral and written communication in English
- Skills in administrative tools (Office 365, Teams, Outlook,), WebApp. SAP knowledge is a plus.
- Basic knowledge in biology or Medical devices would be a nice to have
- Pro-active attitude and able to take initiatives
- Team spirit and collaborative work among peers and with department members
- Excellent sense of service, good sense of adaptation, great organizational, ability to prioritize, rigor, methodical approach

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