Senior Study Start-Up Specialist

Job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Responsible for start-up activities in Belgium and provides local expertise. Identify gaps and areas for improvement and propose CAPA. The Start-up specialist is responsible for collaborating closely with the Regional Clinical Operations Manager/Start-up Lead to ensure study timelines are adhered to and required quality standards are maintained. CRA experience is considered a plus SSUS activities: Provide country-specific study start-up expertise, assist on start-up activities, provide support in budget and contract negotiations Retrieves essential documents from study site and performs essential document site file reconciliation. Perform independent quality review of submission packages, submit package to EC (and HA), if required. Review and translate drug labels, ICF, site specific recruitment materials and other applicable documents. Manages sites and site...