Clinical Trial Manager

il y a 3 jours

Lyon, France ADOCIA Temps plein

Adocia is a French clinical-stage biotech company. The core activities of the company are to innovate, to discover and to develop new therapeutic solutions to improve the lives of people suffering from chronic metabolic diseases, such as diabetes and obesity. Adocia innovative products share a common goal: to improve treatments, bringing new medical benefits to patients and covering unmet medical needs. Relying on disruptive technology platforms, Adocia solutions range from innovative formulations of already-approved peptides and proteins to cell therapy.

Adocia pipeline relies on 4 proprietary technology platforms, BioChaperone®, AdoShell®, AdOral® and AdoGel®, with proprietary specialty products in clinical trials ranging from Phase 1 to Phase 3.

**Poste**:
Reporting to the Director of clinical and non-clinical development, and in close collaboration with multidisciplinary teams, you will be involved in the full process of clinical studies monitoring.

In particular, you will:

- insure the coordination of Clinical trials and manage the interaction with the designed CROs,
- review the clinical trial documents
- follow-up the logistics and the subcontractors,
- participate to meeting with Investigators / Clinical team at Investigational Center,
- be responsible for site co-monitoring, monitoring reports validation and other monitoring activities in compliance with Good Clinical Practices,
- coordinate the risk mitigation strategy.

You will also participate in the CRO selection, the investigational site selection and validation, the preparation of the clinical documentation, the TMF management as well as review and validate the documentation prepared by the CROs (ICF, CRF, Data Management Plan, Monitoring Plan, Safety Plan ).

**Profil**:
You have at least an MSc in Science with relevant experience (5+) in clinical trial management within a CRO or in the pharmaceutical industry and possess the following skills:

- A strong knowledge of GCP with up-to-date training.
- Good knowledge of early clinical development (phase 1 and 2)
- Experience in FDA regulated clinical trials

In addition, you are fluent in English (written and spoken). A proficiency in French (spoken) is an asset.

You also have strong interpersonal skills and a strong inclination for teamwork.

Driven by Science and Innovation, you enjoy working in a high paced and ambitious industrial environment. Adocia promotes excellence in order to bring the best drugs to the patients and to become a valuable partner for large pharmaceutical corporations.

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