Clinical Study Manager (6 months)
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 organization, based in Henegouwen Belgium.
Our Client is a fast growing Biotech Company.
ROLE DESCRIPTION
In the role as study manager you are responsible for the management of the clinical project from a-z.
RESPONSIBILITIES
- Management and coordination of trials : phase II and III
- Participate in study design and protocol development
- Scientific and medical writing - study related documents
- Preparation of regulatory documents/submission files to EC (CA)
- Site Relationship: investigators, site selection, initiation visits, investigator agreement preparation, organization of investigator/meetings
- Management of CRO and monitoring activities
- Review of clinical trial data, support in preparation of study reports
- Contribution to Safety Management: reporting, notification of safety events – follow up and safety report preparation
- Development of credible relationships with KoL, Investigators, and key stakeholders
REQUIREMENTS
- Master in science = minimum
- 3+ years of experience in Clinical Operations
- 2+ years of experience in study monitoring/CRA
- Good knowledge of GCP - ICH principles
- Able to work within Start up and Biotech environment in a quickly growing structure
- Reactive to deadlines, pro-active, dynamic and problem solving
- Fluent: English & Dutch
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.
