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Senior Manager, Global Clinical Process Governance

BeiGene, Ltd.

United Kingdom

Remote

GBP 40,000 - 60,000

30+ days ago

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Job summary

Join a forward-thinking global oncology company as a Senior Manager in Global Clinical Process Governance. This role is pivotal in ensuring compliance with clinical processes and regulations, fostering collaboration among stakeholders, and driving continuous improvement initiatives. You will be at the forefront of enhancing clinical operations, supporting audits and inspections, and maintaining quality metrics. If you are passionate about making a difference in the fight against cancer and thrive in a dynamic environment, this opportunity is perfect for you. Be part of a diverse and innovative team dedicated to improving access to cancer treatments worldwide.

Qualifications

  • 5+ years in pharmaceutical/biotech with clinical operations experience.
  • Strong knowledge of ICH-GCP and compliance management.

Responsibilities

  • Implement and maintain Global Clinical Process Management Governance Framework.
  • Manage stakeholder consultation and endorsement of process changes.

Skills

Fluent English (Oral; Written)

Interpersonal Skills

Problem-Solving

Negotiation Skills

Conflict Resolution

Organizational Skills

Quality Management

Process Improvement

Presentation Skills

Education

Bachelor’s degree

Master’s or other relevant postgraduate qualification

Tools

Microsoft Excel

Microsoft Outlook

Microsoft Word

Microsoft PowerPoint

Microsoft Project

Job description

Senior Manager, Global Clinical Process Governance

Apply locations: United Kingdom, Remote

Time type: Full time

Posted on: Posted 2 Days Ago

Job requisition id: R27241

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 processes 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 postgraduate 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 a matrix environment and in global teams
  • Excellent interpersonal, problem-solving, negotiation and conflict resolution skills
  • Excellent organizational skills and a predisposition 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:

  • 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.

About Us

BeiGene 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 BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

To Mainland China Candidates

For more information, please visit the link to explore job opportunities in China Mainland.

At BeiGene, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.
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