Clinical Trial Assistant
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 Medical Devices organization, based in Brussel Belgium.
Our client is a leading company in health and hygiene.
ROLE DESCRIPTION
In this role you will provide support to the clinical study staff within the Medical Devices franchise
RESPONSIBILITIES
- Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
- Preparation of the Investigator Site File.
- Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site File). Respond to problems and assists in implementing corrective and preventive actions.
- Assist in providing internal communication of important clinical data and events.
- Supports ongoing use of CTMS
- Assist in tracking of study activities as applicable and documents relating to such activities.
- Coordinate with clinical project managers/leaders and site monitors for site concerns/issues.
- Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
- May be involved in other tasks to support Clinical Operations and Operating Company as needed.
REQUIREMENTS
- Know, understand, incorporate, and comply with all applicable laws and regulations relating to business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
- May be asked to provide additional administrative support to Clinical Operations staff, as needed.
- Device ordering/shipment/accountability, if required and if applicable.
- Assists in shipment and tracking of site files & images, as applicable
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.
