[Hiring] Clinical Research Manager @BeiGene

Role Description

Acts as line manager for trial monitoring staff (CRAs) in the given country. Responsibilities include:

• Planning, assigning, and directing work.
• Assessing performance and guiding professional development of direct reports.
• Participating in selection for hiring and allocation of resources to clinical research projects.
• Demonstrating a high level of clinical operations knowledge, organisational skills, project management, and leadership competencies.
• Adhering to ICH/GCP and ensuring clinical trial protocols are executed at clinical trial sites in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs.
• Collaborating closely with the Regional Clinical Operations Manager to ensure study timelines are adhered to and required quality standards are maintained.
• Supporting start-up and providing local expertise.

Essential Functions:

• Managing study start-up and trial monitoring staff in accordance with BeOne’s policies and applicable regulations.
• Participating in the selection for hiring new employees and ensuring proper onboarding and training.
• Managing the quality of assigned staff's clinical work through regular review and evaluation.
• Providing country-specific study start-up expertise to study start-up team leads and project teams.
• Reviewing study start-up document templates, drug labels, ICF, and other applicable documents.
• Helping to develop and review site-specific recruitment materials and tools.
• Collaborating with Regional Clinical Operations Manager and clinical study sites to achieve timely and complete IRB/EC submissions.
• Ensuring TMF completeness and successful delivery of country site commitments.
• Contributing to feasibility, site identification, selection, and evaluation.
• Performing accompanied visits of CRAs to assess their performance.
• Reviewing visit reports and following up on issue resolution.
• Ensuring that staff are meeting defined workload and quality metrics.
• Anticipating and identifying site issues; proposing CAPAs and identifying gaps.
• Constantly striving for operating excellence and promoting innovation.
• Contributing to Clinical Operations strategy and performance against key metrics.

Qualifications

• Bachelor’s degree (or equivalent) or higher in a scientific, medical, or healthcare discipline.
• Minimum 5-7 years progressive experience in clinical operations within the biotech/pharmaceutical sector.
• Prior clinical trial experience including experience in a management/leadership capacity.
• Experience in oncology is highly recommended.

Requirements

• Ability to work independently and effectively handle multiple priorities in a fast-paced environment.
• Minimum of 5-7 years progressive experience in clinical operations, preferably including at least 2 years of line management in the pharmaceutical or CRO industry.
• Excellent interpersonal skills and strong organizational skills.
• Fluent in German & English (writing and speaking).

Benefits

• Salary Range: 83,400.00 EUR - 104,300.00 EUR.
• Travel: up to 30-40%.
• Mentoring and managing junior staff and Clinical Research Associates.
• Conducting mid-year and year-end performance appraisals for direct reports.

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