Clinical Trials Manager
SIRE Life Sciences®
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SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Biotechnology and Clinical Research organisation, based in Gelderland Netherlands.
The CompanyOur client is a professional Pharmaceutical and Healthcare organisation, based in Nijmegen. Our client is active in the field of clinical-stage, discovering and developing therapies targeting a rare disease. They carry their own line of products which they create themselves. A dynamic and upcoming biotech company with an open culture and an innovative drive.
Role DescriptionThe clinical trial manager will be responsible for phase II trial and upcoming new trials for 2020. International sites are based in North-West Europe. It's a varied role where you will be able to build up clinical research, site selection and vendor management. You will be the only person that carries out CT-work within the organization. Close contact with C-level and reports directly to the CEO.
ResponsibilitiesYou are responsible for managing current and upcoming new clinical trials, executed in compliance with ICH/GCP guidelines. You will assist in vendor activities and sites (pre-study site evaluation and new site initiations) and build relationships. Ensuring quality and resolution of site-related issues by reviewing monitoring reports is key in this job. Furthermore you will develop and follow a framework of SOP development to ensure the company will maximize the value and benefits.
Requirements- MD or MSc degree in Biomedical Sciences or related area
- At least 5 years of relevant work experience in clinical trial management in a pharmaceutical or CRO environment
- Experience with phase I - III in rare diseases
- Excellent verbal and written communication in English, Dutch is a pré
- Working knowledge of ICH/GCP regulations and clinical protocols
- Experience in vendor- and site management
Other information- Ability to travel up to 10 - 20%
- Accommodates a flexible work schedule according to clinical trial(s) priorities
- Perform job duties with minimal supervision and guidance
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Bram Reulen.