BeiGene 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.
General Description:
- Line manage Study Start-Up (SSU) and Clinical Trial Manager Associates within country.
- Accountable for delivering country SSU and CTMA within established timelines with high quality and in accordance with ICH/GCP, BeiGene SOPs, and local regulations.
- Ensures SSU and CTMA clinical trial activities are executed to expected and specified timelines and quality standards.
- Gathers and monitors activities to measure against KPIs
- Actively drives best practices and process improvement to achieve corporate goals effectively
- Proactively seeks opportunities to lead and drive improvements to optimize efficiencies within the SSU & CTMA country team as well as within the EU and Global region.
- Key contact for onboarding and process improvement in the country.
Essential Functions of the job:
- Demonstrates mastery of skills required to conduct SSU and CTMA maintenance activities from site identification through activation.
- Provide country-specific SSU and CTMA expertise to project teams
- Assignment as SSU and CTMA 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 and CTMA resources
- 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 of submissions 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.
- Supporting Clinical Trials
- Supports study teams with Clinical Operations tasks, and/or support compilation and quality of the trial master file (TMF)
- Overview of regulatory support after approvals, including submission of core documents to the sites and Regulatory Authority, and Annual/Final reports to Regulatory Authorities.
- Facilitate SSU and CTMA Forum discussions.
- Support review of essential documents
- Ensure completion of SSU and CTMA data entry in CTMS, if applicable
- Support in the development of local workflows to streamline output and deliverables.
- Manage vendors qualification until final setup in country. Point of contact with vendors for issues/alignment
- Overview the translation process for ethical and regulatory documents.
Supervisory Responsibilities:
Line management – BeiGene
- 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 and provide guidance..
- Participate in regular meetings with FSP leadership team.
- Meet with FSP line manager(s) to ensure timely feedback.
Education Required:
A bachelor’s degree or higher in a scientific or healthcare discipline is preferred, as is a minimum of 5 years of progressive experience in clinical research and clinical operations, preferably within the biotech, pharmaceutical sector, or CRO environment.
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
- Fluency in both verbal and written in Polish and English.
Travel: Up to 10%
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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 and we value diversity. BeiGene 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.
