Study Manager Clinical Research
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 Pharmaceutical organization, based in Belgium.
Our client is a professional Biotechnologie organization. The origin of our client is based on the campus of VU Brussels, on this location its start-up was established. Main focus of therapeutic area concerns auto-immune related diseases and oncology.
In this role you will be in charge of the for clinical operational management and supervision of clinical studies within the clinical development program. There will be close cooperation with the clinical lead and CMO.
Manage the complete spectrum of study aspects, including protocol concept to clinical study report
- Supervise performance of CROs and third party vendors
- Ensure compliance with study protocol and in accordance with scope of work
- Ensure studies are carried out according to study protocol, SOPs and ICH/GCP regulations
- Develop and manage study budget
- Initiate study milestones
- Track and report progress of study
- Preparation of study related materials, (study protocols, informed consent, case report forms)
- Make sure operational plans are developed, (recruitment plan, monitoring plan, clinical supplies management, laboratory manual)
- Make sure that SUSARs reporting is established and maintained during the study
- Identification and selection of investigational sites. Oversee study fee negotiations
- Develop an ongoing data review plan to ensure that study objectives are met
- Develop and maintain good working relationships with investigators and study staff
- Interaction with cross-functional internal - & external team
- MSc in bio-medical sciences or other equivalent field
- Minimum 3 years of experience in managing industry sponsored clinical studies, including management of CRO/external vendors
- Oncology experience is a plus
- Experience in managing multi-country studies is preferred
- Quality minded, rigorous, independent and customer oriented
- Good understanding of GCP regulations and guidelines
- Experience with an electronic data capture system
- Able to motivate both the internal and external team in working efficiently
- Fluent in English (written and spoken);
- Strong management skills, Well organized, hands-on,
- Flexible and result focused
- Mindset to set priorities and take initiative
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.