Senior Clinical Research Manager

About the role

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. This role also serves as a line manager, leading a team to achieve organizational goals and ensuring high performance by providing guidance, support, and development opportunities while promoting a positive team culture.

Responsibilities

• 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.
• Manage and address 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: 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.
• 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.
• 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.
• Recruitment and Onboarding: Perform 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 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.

Qualifications

• 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.

Skills

• Proficient in Microsoft Word, Excel, PowerPoint and Outlook.

Benefits

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Pay

$136,400.00 - $181,400.00 annually

Schedule

N/A