General Description:- Accountable for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne SOPs, and local regulations.
- Ensures SSU clinical trial activities are executed to expected and specified timelines and quality standards.
- Gathers and monitors start-up metrics to measure against KPIs.
- Actively drives best practices and process improvement to effectively achieve SSU goals.
- Proactively seeks opportunities to lead and drive improvements to optimize efficiencies within the SSU Team as well as the within the greater Americas region (U.S., Canada, Latin America).
- Lead for central IRB set-up through close-out.
- Key contact for SSU onboarding and process improvement in the Americas.
Essential Functions of the Job:
- Demonstrates mastery of skills required to conduct SSU activities from site identification through activation.
- Provide country-specific SSU expertise to project teams.
- Assignment as SSU Lead back-up support as needed for direct or functional reports’ studies.
- Proficient in communication and influencing skills to ensure timely follow-up, issue resolution, and report updates.
- Manage and maintain SSU resources (i.e., SSU Toolbox (Americas)).
- Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs.
- Site Feasibility
- Skilled in engaging sites during feasibility to efficiently execute CDAs and collect key
information to support with site identification and selection; Liaise with internal stakeholders (i.e., CRAs, FMDs, CSMs) as needed. - Build knowledge in therapeutic area and sites to provide strategic recommendations to teams on potential first site(s) to be selected/activated to achieve FPI.
- Site Start-Up
- Skilled in driving kick-off and completion of tasks from selection through activation.
- Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible.
- ICF/Submissions
- Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out.
- Skilled in document preparation and submission to central IRB to ensure timely reviews.
- Facilitate SSU Forum discussions.
- Support in the development of local workflows to streamline output and deliverables.
- Manage resource allocations and participate in resource forecasting activities.
- Contribute to the ongoing improvement of SSU infrastructure in the Americas – in the U.S., Canada, and Latin America.
- Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals.
Supervisory Responsibilities:
- Line management – BeOne
- Interview and onboard new hires; ensure ongoing training compliance.
- Conduct regular 1:1s to assess workload, provide feedback, track goals, develop team.
- Conduct mid-year and year-end performance check-ins and reviews.
- Functional management – FSP
- Onboard new hires; ensure ongoing training compliance.
- Conduct regular 1:1s to assess workload, provide guidance, mentor and develop team.
- Participate in regular meetings with FSP leadership team.
- Meet with FSP line manager(s) to ensure timely feedback.
Computer Skills:
- Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams
Other Qualifications:
- Knowledge in the execution of clinical trials, understanding of ICH/GCP
- Effective prioritization of tasks in the achievement of goals
- Strong written and verbal communication skills
- Highly organized
- Diligence in follow through
- Skilled in risk mitigation
- Line management experience
- Functional Service Provider model knowledge and/or experience
- Mentoring and training team members
Travel:
Education/ Experience Required:
- Bachelor’s degree or higher in a scientific or healthcare discipline preferred with minimum of 7+ years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, or CRO 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.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
Salary Range: $136,400.00 - $181,400.00 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.
