Project Manager specialized in study start-up activities in France

We are looking for the earliest possible start date an experienced Project Manager specialized in study start-up activities in France for our Clinical Research department, home based

AMS Advanced Medical Services has been operating successfully throughout Europe as a Contract Research Organization (CRO) in the field of Clinical Research since 1997. Renowned pharmaceutical and medical device companies are among our regular customers. Our company is characterized by team spirit, fairness and the joy of working together.

Your tasks:

·       Setting-Up of national and international Clinical Studies in France

·       Creating of trial documents (e. g. plans and templates)

·       Acting as a primary point of contact between sites and sponsor

·       Conducting, driving and managing feasibility in France

·       Conducting, driving and managing site pre-qualification and qualification activities

·       Preparing and negotiating of Confidentiality Agreements (CDA) and Site Contracts

·       Developing strategy to configure, distribute, collect, review and approve high quality France specific and/or site-specific documents or essential regulatory documents

·       Adapting, reviewing, and negotiating France specific ICFs (including quality check of translations and implementation of country, regulatory, and sponsor requirements)

·       Preparing and submitting of application files to CPP, ANSM or via CTIS portal

·       Managing applications or notifications to CNOM, CNIL, transparency portal

·       Advising AMS personal and/or sponsors with respect to French legal requirements before bid meeting and during study set-up

·       Managing project teams

·       Managing budget of projects

·       Maintaining and intensifying customer relations

Your profile:

·       A degree in life science

·       At least 3 years of experience in study set up activities in France, including practical experience in submission to CPP, ANSM, CNOM, CNIL, for observational and interventional studies, with medicinal products and medical devices

·       Experience as a Project Manager

·       Very good oral and written communication skills, organized, rigorous, concise, result-oriented way of working

·       Personal responsibility, working independently and time flexibility

·       Willingness to develop further in the new area of EU-HTA

·       Fluent in French, very good English and MS Office skills

What we offer:

·       A professional, collegial, open-minded, friendly team who enjoy their work

·       Flat hierarchies

·       Flexible working hours including home office

·       Excellent development opportunities in a growing company

Are you interested?

Please send your application to and provide CV in English and a motivation letter in French including your salary claim.

Your AMS Recruiting Team

AMS Advanced Medical Services GmbH

Am Exerzierplatz 2, 68167 Mannheim, Germany

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