Global Study Management Associate

Job Title: Global Study Management Associate Job Location: Remote (US) Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: 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: · Supports the Global Clinical Study Manager in global study delivery and ensures that delegated components of clinical studies are executed to expected and specified quality standards, within timelines and budget · Supports the alignment of study goals with clinical operations goals and objectives under direction of the Global Clinical Study Manager Essential Functions of the Job: Cross-Functional Leadership Support & Collaboration · Supports the Global Clinical Study Manager with the organization and logistics for cross-functional Clinical Study Team (CST) meetings · Establishes good collaboration with the Global Clinical Study Manager, Regional Clinical Trial Management Associates and other key stakeholders globally and regionally · Knowledgeable of clinical study operations, including interpretation and implementation of regulatory and ICH-GCP guidelines · Builds solid knowledge of global clinical trials operations under the guidance of the Global Clinical Study Manager Planning and Execution · Creates and maintains study-level SharePoint and CST distribution lists · Sets up the study in the appropriate systems e.g. eTMF, CTMS etc and makes sure study-level information is kept up to date · Ensures system access is granted and managed appropriately across the study life cycle, supports user account management for systems used in the study · Supports the development of various study plans · Organizes study-specific investigator meetings under supervision of the Global Clinical Study Manager · Might support the creation and review of site feasibility assessments required for study participation · Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations in relevant systems in collaboration with Regional Clinical Trial Management Associates · Prepares metrics and updates to key deliverables for management as per information available in relevant systems · Supports the preparation of a study newsletter and other...

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