Clinical Study Manager
Location: BelgiumSIRE 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!
THE COMPANY
Our client is a professional Biotechnology and Clinical Research organization, based in Flandre Orientale Belgium.
Our client is a fast growing biotech company specialized in using cell therapy
ROLE DESCRIPTION
In this role you will be responsible for the management and coordination of clinical trials in phase II and III
RESPONSIBILITIES
- 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
REQUIREMENTS
- 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.
