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 Pharmaceutical organization, based in Flandre Orientale Belgium.
Our client is a professional Central Lab organisation, based in Brussels.
ROLE DESCRIPTION
In this role you will be responsible for operational management and oversight of clinical studies within the clinical development program and you will work closely with the clinical lead and CMO.
RESPONSIBILITIES
- Manage all aspects of study (the protocol concept through the 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
REQUIREMENTS
- Master degree (bio-medical sciences (or related) or relevant experience in similar position in the Biotech/Pharma industry.
- Minimum 3 years of experience in managing industry sponsored clinical studies, including management of CRO/external vendors
- Oncology experience is preferred
- Experience in managing multi-country studies is a plus
- 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;
- Strong management skills, Well organized, hands-on, Flexible and result focused
- Power 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.
