Senior Project Manager (Freelance Consultant)

For one of our clients in manufacturing sector we are seeking a Senior Project Manager to support critical projects focused on User Access Management (UAM) and Data Management Process improvements. These role involves overseeing the implementation of business rules, data accuracy, and system updates in a clinical trial setting, ensuring compliance and efficiency across multiple key deliverables.

Key Responsibilities:

• User Access Management Process: Map the UAM process from both an investigator site staff perspective and a trial-centric perspective, covering the full study lifecycle.
• Project Coordination: Ensure timely and full provision of critical activities including helpdesk performance analysis, access provisioning, and change management plans, keeping all tasks on track and aligned with sponsor expectations.
• Business Rules & R&R Matrix: Establish and implement business rules for data entry and a clear R&R (Roles & Responsibilities) matrix for maintaining data integrity across 21 key parameters.
• Data Monitoring & Retrospective Cleaning: Define metrics, select tools for monitoring data accuracy, and execute a data cleaning plan to achieve 95% accuracy.
• CTMS System Enhancements: Oversee system updates (e.g., pop-ups, instructions) and ensure alignment with process maps and governance.
• Training & Change Management: Develop and implement training and change management plans to ensure smooth adoption of new processes and tools.

Requirements

Key Qualifications:

• Proven experience in managing long-term process improvement projects in a clinical or highly regulated environment.
• Strong understanding of data management and compliance, with experience implementing change management strategies.
• Ability to coordinate cross-functional teams and drive successful project outcomes through structured planning and execution.
• Fluency in English

This is a role for an independent consultant with initial contract of 3 months. Start date mid October 2024.