Senior Manager, Site Management

About us

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing,and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).

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.
Job Description:

General Description:
The Senior Clinical Research Manager oversees clinical monitoring activities and the CRA team's performance to ensure they comply with ICH-GCP, local regulations, and company SOPs, and maintain quality across clinical trials. As a line manager, this role leads a team to achieve organizational goals and ensure high performance by providing guidance, support, and development opportunities while promoting a positive team culture.
Essential Functions of the Job:
Team Resource Allocation & Performance

- Allocate CRA resources and perform ongoing resource assessments to ensure a balanced workload for quality monitoring and to meet study deliverables.

- Ensure CRAs have the required level of monitoring knowledge and skills to successfully perform required activities with high quality to meet study deliverables.

- Is responsible for managing and addressing CRA performance and quality indicators in accordance with ICH-GCP, SOPs and local regulations.

- Strengthen site relationships to enhance performance and uphold the company’s trial delivery reputation.

Quality and Compliance

- Review monitoring quality and resolve issues to ensure compliance with regulatory guidelines, ICH-GCP Guidelines, and Good Clinical Practices.

- Support study/site milestone delivery in collaboration with cross-functional teams.

- Responsible for execution of assessment visits and accompanied visits (where required) to assess ongoing CRA monitoring competency, identifying issues and developing resolution strategies.

- Contribute to process optimization initiatives and manage risk escalation and resolution.

- Support site audits/inspections/Site Compliance Visits (SCV) and ensure corrective action and follow-up for identified issues.

Expense Review and Management

- Review and approve expenses related to CRA activities to ensure alignment with applicable policies and financially best local practices.

- Identify opportunities for cost-saving and efficiency while maintaining quality and compliance standards.

Mentoring

- Provide mentorship and guidance to junior Clinical Research Managers (CRMs), supporting their professional growth and development if required.

- Facilitate learning opportunities and provide valuable insights and feedback to help upskill and promote consistency within the wider team.

Leadership of Taskforce and Initiatives
- Lead and contribute to strategic initiatives and task forces aimed at improving clinical operations processes and outcomes, driving projects from inception to completion in alignment with organizational goals and in collaboration with cross-functional teams.

Supervisory Responsibilities:
Recruitment and Onboarding: Performs recruiting and hiring activities, along with onboarding new team members to ensure alignment with team objectives and culture.
Task Assignment: Assign tasks based on individual strengths and team objectives, ensuring optimal productivity.
Support and Reso