Senior Study Start-Up Specialist
General Description:
Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne's SOPs, and local regulations.
Essential Functions of the job:
ā¢ Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
ā¢ Contribute to discussions during the feasibility state of site selection
ā¢ Site Start-Up:
ā¢ Skilled in driving kick-off and completion of tasks from selection through activation, including providing timeline input for site activations.
ā¢ Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible.
ā¢ ICF/Submissions:
ā¢ Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.
ā¢ Skilled in document preparation and submission to central IRB to ensure timely reviews.
ā¢ Ensure collection and review of essential documents
ā¢ Complete SSU data entry in CTMS
ā¢ Complete timely and quality eTMF filing
ā¢ Support in the development of local workflows to streamline output and deliverables
ā¢ Contribute to the ongoing improvement of SSU infrastructure in North America
ā¢ Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals
Supervisory Responsibilities:
ā¢ Not applicable
Education/Experience Required:
ā¢ Bachelor's degree or higher in a scientific or healthcare discipline preferred
ā¢ Minimum of 3 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.
Global Competencies
When 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.
ā¢ Fosters Teamwork
ā¢ Provides and Solicits Honest and Actionable Feedback
ā¢ Self-Awareness
ā¢ Acts Inclusively
ā¢ Demonstrates Initiative
ā¢ Entrepreneurial Mindset
ā¢ Continuous Learning
ā¢ Embraces Change
ā¢ Results-Oriented
ā¢ Analytical Thinking/Data Analysis
ā¢ Financial Excellence
ā¢ Communicates with Clarity
Salary Range: $83,800.00 - $113,800.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related 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 base 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. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all 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.
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Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne's SOPs, and local regulations.
Essential Functions of the job:
ā¢ Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
ā¢ Contribute to discussions during the feasibility state of site selection
ā¢ Site Start-Up:
ā¢ Skilled in driving kick-off and completion of tasks from selection through activation, including providing timeline input for site activations.
ā¢ Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible.
ā¢ ICF/Submissions:
ā¢ Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.
ā¢ Skilled in document preparation and submission to central IRB to ensure timely reviews.
ā¢ Ensure collection and review of essential documents
ā¢ Complete SSU data entry in CTMS
ā¢ Complete timely and quality eTMF filing
ā¢ Support in the development of local workflows to streamline output and deliverables
ā¢ Contribute to the ongoing improvement of SSU infrastructure in North America
ā¢ Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals
Supervisory Responsibilities:
ā¢ Not applicable
Education/Experience Required:
ā¢ Bachelor's degree or higher in a scientific or healthcare discipline preferred
ā¢ Minimum of 3 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment.
Global Competencies
When 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.
ā¢ Fosters Teamwork
ā¢ Provides and Solicits Honest and Actionable Feedback
ā¢ Self-Awareness
ā¢ Acts Inclusively
ā¢ Demonstrates Initiative
ā¢ Entrepreneurial Mindset
ā¢ Continuous Learning
ā¢ Embraces Change
ā¢ Results-Oriented
ā¢ Analytical Thinking/Data Analysis
ā¢ Financial Excellence
ā¢ Communicates with Clarity
Salary Range: $83,800.00 - $113,800.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related 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 base 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. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all 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.
Apply Now
Apply Now