Senior Manager - Global Clinical Process Governance

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Public Relations • Press Release Distribution • Investor Relations • SEC filing • SEO

501 - 1000 employees

Founded 1961

Description

• Responsible for the implementation and maintenance of the Global Clinical Process Management Governance Framework • Working collaboratively with cross functional stakeholders • Ensure compliance with ICH-GCP and regulatory requirements • Primary GCOE point of contact for GCO process governance • Supports Global Clinical Process Management Leads with document review and continuous process improvement • Manages stakeholder review, consultation, and endorsement of changes • Supports timely creation, revision, release or retirement of communication and learning materials • Maintains performance and quality metrics related to processes • Establishes successful partnerships with relevant GCO and cross-functional groups and other stakeholders

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 • Efficient in Microsoft suite (Excel, Outlook, Word, PowerPoint, Project) • Six sigma certification and/or experience with process mapping desirable.