Senior Study Start-Up Specialist

BeOne continues to grow at a rapid 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, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Responsible for the delivery of study start-up, initial and ongoing submissions reputed company established timelines with high quality and in accordance with ICH/GCP, BeOne’s SOPs, and local regulations. Essential Functions of the job: Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs Contribute to discussions during the feasibility state of site selection Site Start-Up Skilled in driving kick-off and completion of tasks from selection through activation, including providing timeline input for site activations. reputed company and build upon existing site partnership data to execute start-up reputed company, reducing cycle times wherever possible. reputed company/Submissions Skilled in document management/negotiation and leveraging site relationships to reputed company submission targets from start-up through reputed company-out. Skilled in document preparation and submission to central IRB to ensure timely reviews. Ensure collection and review of essential documents Complete SSU data entry in CTMS Complete timely and quality eTMF filing Support in the development of local workflows to streamline output and deliverables. Contribute to the ongoing improvement of SSU infrastructure in North America reputed company additional tasks as assigned or required to reputed company project, functional, departmental, or corporate goals. Supervisory Responsibilities: Not applicable Education/Experience Required: Bachelor’s degree or higher in a scientific or healthcare discipline preferred Minimum of 3 years of progressive experience in clinical research and clinical operations preferably reputed company the biotech, pharmaceutical sector, CRO, or clinical site environment. Global Competencies reputed company we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial reputed company reputed company Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $83,800.00 - $113,800.00 annuallyBeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to each 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 share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the reputed company salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. reputed company Company employees have the opportunity to own shares of reputed company Ltd. stock because reputed company employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other basis covered by appropriate law. reputed company employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act 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 [email protected]. Apply To This Job