Senior Study Start-up Manager

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

PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION

Language Requirement: Fluent English required. Spanish is a plus

Preferred Experience: Pharmaceutical/Biotech Industry, Hematology, Oncology

Location: Sao Paulo Hybrid (2 to 3 days per week in the office)

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:

• Demonstrates mastery of skills required to conduct SSU and maintenance activities.
• 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
  • Build knowledge in therapeutic area, regulatory requirements 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.
  • Overview submissions dossiers to Ethics Committees and Regulatory Authorities according to applicable regulations, SOPs and work instructions.
  • Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines.
• 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.
• Overview regulatory support after approvals, including submission of core documents to the sites and Regulatory Authority, and Annual/Final reports to Regulatory Authorities.
• 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.

Overview the translation process for ethical and regulatory documents.

Minimum Requirements – Education and Experience:

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.

Other Experience:

• 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

Supervisory Responsibilities:

Line management – BeOne

• Interview and onboard new hires.
• Support the training of the more juniors SSU Managers.

Functional management – FSP

• Onboard new hires.
• Participate in regular meetings with FSP leadership team.

Meet with FSP line manager(s) to ensure timely feedback

Travel:   up to 10%

Computer Skills:  Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint, Teams

#LI-Remote

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

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 origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.