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Start up Specialist (m/v)

Réf 1266438

Actualisé le 09 septembre 2020 par LAB SUPPORT

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For one of our clients we are urgently looking for a Start up specialist. Job description The ClinOps Department will be involved in several new projects and needs the support of an additional Local Study Lead. The Local Study Lead (LSL) is responsible for the preparation of a clinical trial according to quality standards and timelines in their OPU, as well as cross-functional collaboration during conduct. Responsibilities In preparation phase: * Participate in team meetings initiated by CML or study team and provide information on the status of the study. * Ensure that local adaptations to monitoring manual are made (if needed). * Identify, select and manage vendors on local level * Maintain Trial Master File (TMF) up to date. * Ensure input is timely given for completeness of CTMS. * Check and prepare on-site logistics e.g complete IRT shipping forms * Collect essential documents for submission in collaboration with CRA, CTA officer and PM. * Preparation of local Subject Information (SI)/Informed Consent Form (ICF) and other required trial documents for submission, TMF and Investigator Site Files (ISFs). * Conduct and document Pre-trial contacts and support the site selection process * Arrange supplies/materials/NIMP/equipment in collaboration with COL * Provide site and trial information to COL for budget and contract negotiations. In initiation phase: * Ensure proper handover of trial to CRO-CRA * Participate in the Trial Initiation visit at site together with the CRO-CRA and ensures that the site staff is trained in protocol and related documents and procedures. * Ensure that all essential documents are available before initiation, * Maintain TMF up to date on OPU and site level * Ensure completeness of CTMS In conduct phase: * Support CTA officer with adaptation of documents for substantial amendment submission . * Adjustment of local SI/ICF and other required trial documents for submission (substantial amendment) . * Support audits and inspections on site ...
  • Studies, onderzoek en ontwikkeling / Studies in de economische, sociale en menswetenschappen

Comment postuler ?

Nom de l'employeur
Personne de contact
Mr Belgium Stepstone
Mode de présentation

solliciteren via Web site

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