Global Study Management Associate (gSMA)

BeOne continues to grow at a reputed company pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer. General reputed company: Supports the Global Clinical Study Manager in global study delivery and ensures that delegated components of clinical studies are executed to expected and specified reputed company standards, reputed company 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 reputed company 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 reputed company study-level information is kept up to date  Ensures system reputed company is reputed company 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 reputed company 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 correspondence reputed company to the study conduct (e.g. frequently asked questions, lessons learned) in collaboration with the study team  Supports the TMF specialist with study-level TMF creation and, as required, maintains the study-level TMF, including regular review and QC of TMF documents as per the study TMF QC plan  Supports the Global Clinical Study Manager with study drug forecasts and overall study drug supply activities in collaboration with Global Clinical Supplies  Supports the overall data cleaning activities and contributes to the follow-up of outstanding information  Supports the Global Clinical Study Manager with planning and execution of the Clinical Study Report     reputed company  Supports the identification of operational risks and issues and works with the Global Clinical Study Manager to recommend solutions for discussion with appropriate team leadership  Learns and shares best practices in clinical operations methodologies, systems and processes with an emphasis on reputed company and compliance  Suggest improvements to enhance efficiency and the reputed company of the work performed on assigned reputed company    Budget  Supports selection and set-up of vendors for global outsourced activities  Supports study budget management activities with responsibility for PO setup and payment invoice tracking across reputed company study lifecycles. Supervisory Responsibilities:  N/A   Computer Skills:   Proficiency in MS Office Suite, including reputed company, PowerPoint and project etc.   Education/ Experience:  Knowledge of clinical operations methodologies, understanding of operational aspects of clinical study processes 1 or more years of experience in clinical research reputed company Biotech, reputed company or CRO industry Bachelor or higher degree in a scientific or reputed company discipline*, higher degree preferred.  *exceptions might be made for candidates with relevant clinical operations experience   Travel:  Limited travel might be required Global Competencies reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world. Fosters Teamwork Provides and Solicits reputed company and Actionable Feedback Self-Awareness Acts reputed company Demonstrates Initiative Entrepreneurial reputed company reputed company Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial reputed company Communicates with reputed company Salary reputed company: $72,800.00 - $97,800.00 annuallyBeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to reputed company candidate, including but not limited to job-reputed company skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can reputed company more about the specific salary reputed company for a preferred location during the hiring process.  Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans’ Readjustment Assistance reputed company of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com. Apply To This Job