Clinical Research Manager

BeOne Medicines; São Paulo; Híbrido; BRL 350 000 - 520 000; Tempo integral

Resumo da oferta

BeOne Medicines in Sao Paulo is seeking a Clinical Research Manager to oversee the CRA team, ensuring ICH-GCP compliance and high quality across trials. You will lead monitoring activities, allocate resources, and promote a positive, high-performance team culture in a hybrid work setting.

The ideal candidate has a Bachelor’s in a scientific field, 5+ years in pharma/CRO, and at least 2 years in people management; oncology experience is highly valued and English fluency is required.

Qualificações

• Bachelor’s degree or higher in a scientific or healthcare discipline; advanced degrees preferred.
• Minimum 5 years of industry experience in pharmaceutical, CRO, or related field.
• Minimum 2 years of people or project management experience in clinical research is preferred.

Responsabilidades

• Oversee CRA monitoring activities and team performance.
• Allocate CRA resources and balance workload to meet study deliverables.
• Ensure compliance with ICH-GCP, SOPs, and local regulations.
• Strengthen site relationships to uphold trial delivery.
• Review monitoring quality and address regulatory compliance issues.
• Support site audits and corrective actions as needed.

Conhecimentos

Team leadership

Resource planning

ICH-GCP knowledge

Quality & compliance

Budget management

Cross-functional collaboration

CRA monitoring experience

Oncology experience

Formação académica

Bachelor’s degree in scientific/healthcare

Advanced degree preferred

Ferramentas

Microsoft Office

Descrição da oferta de emprego

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.

Language Requirement: Fluent English is Required

Preferred Experience: Pharmaceutical/Biotech Industry

Location: Sao Paulo Hybrid

General Description

The 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

• 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.

Minimum Requirements – Education And Experience

• Bachelor’s degree or higher in a scientific or healthcare discipline, and advanced degrees preferred.
• Minimum 5 years of industry experience in the pharmaceutical or CRO or relevant field
• Minimum 2 years of People management or project management experience in progressive clinical research within the biotech, pharmaceutical sector, CRO industry or relevant field is preferred

Other Experience

• Fluent in written and verbal English
• 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.

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 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

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

Computer Skills

Proficient in Microsoft Word, Excel, PowerPoint and Outlook

Global Competencies

• 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.