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.
General Description:
* Acts as line manager for clinical study managers (CSMs) in the given country(ies).
* Responsibilities include planning, assigning, and directing work, assessing performance, and guiding the professional development of direct reports.
* Participate in selection for hiring and allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
* Demonstrates high clinical operations knowledge, organizational skills, project management, and leadership competencies.
* Adheres to ICH/GCP and ensures clinical trial protocols are executed according to ICH guidelines and GCP, local regulations, and applicable SOPs.
* Collaborate closely with the regional and country(ies) team, including regional-focused rCSMs, CRMs, the Feasibility Manager, and the Country Head, to ensure study timelines are adhered to and required quality standards are maintained.
* Supports clinical trials in the country and provides local expertise.
* Proactively drives best practices and process improvement to achieve corporate goals effectively.
* Proactively seeks opportunities to lead and drive improvements to optimize efficiencies within the CSM country team.
* Ensures clinical trial activities are executed to expected and specified timelines and quality standards.
Essential Functions of the job:
Staff Management and Oversight
* Provides leadership, management, and/or mentorship to Clinical Study Managers (CSMs)
* Manage CSMs in line with BeOne's policies and regulations.
* Oversee CSM resources and ensure staff meet defined workload and quality metrics through regular review and reporting.
* Participate in hiring and onboarding new employees, ensuring proper training and oversight of training plans.
* Monitor the quality of clinical work and conduct regular evaluations of assigned staff.
* Facilitate CSM forum discussions and provide regular updates to stakeholders.
* Utilize strong communication and influencing skills to ensure timely follow-ups, issue resolution, and reporting updates.
* Supports the development of initiatives and ensures that novel ideas on how to deliver on clinical trials are generated and considered
Study Oversight and Quality
* Ensures team members are trained on and are adhering to required processes and SOPs
* Promotes a quality mindset in the country study management team and supports the proactive implementation of risk management principles.
* Sets clear quality expectations for the country study management team
* Supports the knowledge management and continuous improvement process by ensuring information is captured, retained, and leveraged in future work
* Provide country-specific study management expertise to the team.
* Review and support the development of study start-up templates, drug labels, informed consent forms (ICFs), and other applicable documents.
* Anticipate and address site issues, propose corrective and preventive actions (CAPAs), and identify opportunities for improvement.
* Promote operational excellence, challenge the status quo, and foster innovation in study management processes.
* Contribute to clinical operations strategy, identifying areas for improvement and proposing solutions.
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, and develop the 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:
* Bachelor's degree or higher in a scientific or healthcare discipline preferred, with a minimum of 7 years of progressive experience in clinical research and clinical operations, preferably within the biotech, pharmaceutical sector, or CRO environment, including a minimum of 2 years clinical project manager experience or equivalent.
* Previous direct-line management experience preferred.
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: Occasional
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.