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We are searching for a Trial Setup Manager who will perform day-to-day operational tasks during the setup of a trial for a well known clinical laboratory. They provide the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials. With their global footprint and access to leading regional labs, data, patients, technology, and partnered resources, they support global biotech, pharma, and IVD organizations to improve the lives of patients around the world.
Documentation of the complete setup in a Trial Master File part Set-Up (creation, maintenance and archiving)
Preparation of sponsor study documentation: - Preparation of the Laboratory Specifications, describing the services foreseen in a specific project, based on the Trial Notification Form, clinical study protocol, study budget and communication with the sponsor - Preparation of Central Laboratory Study Documentation
Preparation of site study documentation: - Preparation of Central Laboratory manuals and the English instruction leaflet - Coordinate the translation of leaflets if required - Preparation of the study specific requisition forms - Preparation of other site documentation (eg Sampling Material Request form, Request for dry ice form, Sample log form) - Upload of site study documentation on the Board
Preparation of internal study documentation: - Local trial set-up (NWHL, Cerba, Histalim, subcontracted labs, ¿) - Preparation of the internal study start up document to provide all departments with trial specific directives as established in agreement with the sponsor (MIPS trials only)
Technical preparation of the study database: - Follow-up on test code creation in Master Test Catalogue - Initiation and finalization of study-specific reference ranges - Preparation of CTMS Study Set-up configuration - Cross-review (upper layer QC) sponsor/site/internal study documentation and technical database - Perform other tasks deemed necessary to assure good quality work according to standard operating procedures and agreements made with the sponsors
Only applicable for srTSM role: - Assist in making sure Standard Operation Procedures, process flows and templates are in place to achieve local and global transparency and quality - CTMS set-up superuser (assist Global Process Owner trial set-up in change and issue management, UAT and training of the other users) - Mentor and training of new employees
- Bachelor degree (office management languages/medical or science oriented) - Accurate administrator - Flexible in dealing with problems (related to eg project scope, deadlines) - Good communication skills - Thorough knowledge of standard computer and office applications - Fluent in Dutch and English, notions French
Do you recognize yourself in this description? Send your cv to firstname.lastname@example.org!
what do we offer?
What do we offer? A challenging job with a nice salary!
administrative employee (m/f)
immediate permanent employments
Gezondheidszorg en maatschappelijke dienstverlening