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 visitwww.beonemedicines.comand 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 Resource Provision: Support team members by providing necessary resources to help them effectively perform their roles.
Communication and Collaboration: Encourage open communication and collaboration within the team and with other functions, including acting as a point of contact for issue escalation and feedback where required.
Performance Evaluation: Conduct regular performance evaluations and provide constructive feedback to promote continuous improvement.
Mentoring and Development: Lead and mentor team members, fostering an environment of growth and development.
Issue Resolution: Address any personnel issues promptly and fairly to maintain a positive work environment.
Career Development Support: Support team members in identifying and pursuing professional development opportunities.

Qualification Required:

Education Required:
Bachelor’s degree or higher in a scientific or healthcare discipline, and advanced degrees preferred.

Computer Skills: Proficient in Microsoft Word, Excel, PowerPoint and Outlook
Other Qualifications:

• Fluent in written and verbal English
• Minimum 7 years of industry experience in the pharmaceutical or CRO or relevant field
• Minimum 4 years of People management or project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field is preferred
• Thorough understanding of the drug development process, including expert knowledge of international standards (ICH GCP) and health authority requirements
• Understanding of all aspects of monitoring and trial execution, with previous experience as a CRA preferred
• Excellent interpersonal skills, strong organizational and effective written and verbal communication skills. Demonstrated team leadership experience.
• Experience in Oncology is highly recommended

?Travel: Be adaptable to business trips as required per business need; require valid driver’s license in applicable countries

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme

• Company shares (generous welcome grant!)

• In-house and external learning and development opportunities

• Fantastic benefits program and keep improving!

• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.

• Join us and Make momentum in your career!

BeOne 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

BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.

Originally posted on Himalayas