Clinical Study Manager
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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 organization, based in Brabant Flamand Belgium.
Our client is a fast growing biotech company specialized in using cell therapy
In this role you will be responsible for the management and coordination of clinical trials in phase II and III
- Participate in study design and development of protocol
- Scientific and medical writing (study related documents)
- Preparation of regulatory submission files
- Site Relationship: investigators, site selection, initiation visits, investigator agreement preparation, organizing of meetings
- Management of CRO and monitoring activities
- Review of clinical trial data and support preparation of clinical study reports
- Development of credible relationships
- Review of medical literature and related new technologies
- Minimum an advanced scientific degree - PhD, MD
- 4 years experience in clinical operations
- 2 years experience in Study Monitoring or as a CRA
- Good knowledge of GCP - ICH
- Team player with strong interpersonal and communication skills
- Able to work within Start up and Biotech environment in a rapidly growing structure
- Ppro-active, dynamic and problem solving
- Fluent in English & French
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Hanneke de Koning.