Senior Global Clinical Process Management Specialist

Overview

In this role you coordinate and provide operational support to Process Leads and senior GCPM leadership to enable governance, document control, and timely decision-making. You will gather inputs, maintain project plans, stakeholder materials, and intake data to drive process progression, continuous improvement, and delivery of GCPM initiatives. You’ll compile data from systems like Veeva Vault and support change-management communications to facilitate informed management decisions. This role supports a mission-driven team working to advance cancer therapies in a fast-paced environment.

Responsibilities

• Coordinate document review and approval workflows to ensure timely progression and governance
• Manage document control activities, including initiating engagements, QA alignment, and tracking approvals
• Gather, tabulate, and organize inputs to support Process Lead review and decision-making
• Develop and maintain project plans, status reviews, and follow-up on outstanding information
• Create and maintain stakeholder lists, meeting materials, and project charter drafts
• Provide administrative support for organizational change management communications
• Compile data from Veeva Vault or equivalent sources to support status reporting
• Prepare and maintain QE CAPA tables and related tracking materials for periodic review
• Analyze data from the GCPM intake form to support process improvement and innovation opportunities

Key requirements

• Pharmaceutical and/or biotechnology sector experience (minimum 2 years)
• Knowledge of ICH-GCP
• Fluent English (oral and written)
• Excellent interpersonal and problem-solving skills
• Strong organizational skills with a focus on quality management and process improvement
• Effective verbal and written communication skills
• Proficiency in Microsoft Office (Excel, Outlook, Word, PowerPoint, Project)

• Interpersonal skills
• Problem-solving
• Organizational excellence
• Microsoft Office suite (Excel, Outlook, Word, PowerPoint, Project)
• Veeva Vault (or equivalent)
• Data analysis and reporting

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