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Senior Manager, Global Clinical Process Governance

BeiGene, Inc.

United Kingdom

On-site

GBP 80,000 - 100,000

30+ days ago

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Job summary

An established industry player is seeking a Senior Manager for Global Clinical Process Governance. This role involves implementing and maintaining a governance framework, ensuring compliance with ICH-GCP standards, and driving continuous process improvement. You will collaborate with cross-functional teams, manage stakeholder engagements, and support audits and inspections. If you are passionate about enhancing clinical processes and have a strong background in the pharmaceutical or biotechnology sector, this is an exciting opportunity to make a significant impact in the fight against cancer while working in a dynamic and collaborative environment.

Qualifications

  • 5+ years experience in pharmaceutical/biotech sector required.
  • Fluent in English with strong communication and presentation skills.

Responsibilities

  • Implement and maintain Global Clinical Process Management Governance Framework.
  • Manage stakeholder consultations and endorse process changes.

Skills

Clinical Operations Process Knowledge

ICH-GCP Compliance

Stakeholder Management

Process Improvement

Interpersonal Skills

Problem-Solving

Negotiation Skills

Organizational Skills

Communication Skills

Presentation Skills

Education

Bachelor's Degree

Master's Degree

Tools

Microsoft Excel

Microsoft Outlook

Microsoft Word

Microsoft PowerPoint

Microsoft Project

Job description

BeiGene 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.

General Description:

The Senior Manager, Global Clinical Process Governance is responsible for the implementation and maintenance of the Global Clinical Process Management Governance Framework; Working collaboratively with cross functional stakeholders, to ensure the decisions pertaining to BeiGene GCO standards are appropriately governed and processes are maintained in compliance with ICH-GCP and regulatory requirements.

Essential Functions of the job:

  • Governance Framework: Primary GCOE point of contact for GCO process governance.
  • Continuous Process Improvement: Supports Global Clinical Process Management Leads with document review and continuous process improvement.
  • Stakeholder Management: Manages stakeholder review, consultation and endorsement of changes to process under the responsibility of Global Clinical Process Management OR processes under the responsibility of other functions that impact GCO.
  • Communication and Learning: Supports Global Process Management Leads with timely creation, revision, release or retirement of communication and learning materials and associated content.
  • Audits and Inspections: Supports process related audit and inspection commitments for Global Clinical Process Management.
  • Documentation and Reporting: Maintains performance and quality metrics related to processes under the responsibility of Global Clinical Process Management.
  • Establishes successful partnerships with relevant GCO and cross-functional groups and other stakeholders as required.

Education Required:

Bachelor's degree required, Master's or other relevant post graduate qualification advantageous.

Requirements:
  • Fluent English (Oral; Written)
  • Relevant Bachelor's degree or higher - preferred science/healthcare discipline
  • Minimum of 5 years relevant experience in pharmaceutical and/or biotechnology sector
  • Extensive knowledge of clinical operations process, ICH-GCP and compliance management; including application of clinical trial regulation/s
  • Experience working in matrix environment and in global teams
  • Excellent interpersonal, problem-solving, negotiation and conflict resolution skills
  • Excellent organizational skills and a pre-disposition to quality management and process improvement
  • Effective communicator (oral and written)
  • Strong presentation skills

Computer Skills:
  • Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint, Project)

Other Qualifications:
Six sigma certification and/or experience with process mapping desirable.

Travel: N/A

BeiGene 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

We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.
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