Senior Study Start-Up Manager

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer.

About the role

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 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.

Responsibilities

• 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 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.

Qualifications

• 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.
• 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.

Skills

• Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams.
• Global Competencies:
  • 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

Travel

Up to 10%

Pay

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 unique to each candidate, including 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.

Benefits

• Annual bonus plan (non-commercial roles) or incentive compensation plan (commercial roles).
• Discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan.
• Comprehensive benefits package including:
  • Medical, Dental, Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness programs