Project Manager, Clinical Systems

12 month Daily Rate Contract, Cork

This role focuses on leading the delivery and release management of clinical data systems. You will oversee project lifecycles including implementations and upgrades ensuring they meet quality standards within a regulated pharmaceutical environment.

Key Responsibilities

• Project Delivery: Manage system implementations, upgrades, and integrations from start to finish.
• Documentation: Create and maintain project plans, risk logs, and status reports.
• Coordination: Act as the bridge between IT, quality teams, and outside vendors to resolve issues and track dependencies.
• Release Management: Schedule deployments and manage change requests following strict control processes.
• Testing (UAT): Lead User Acceptance Testing, including planning, tracking defects, and getting final sign-off.
• Compliance: Support system validation activities (CSV/CSA) and data integrity checks to meet GxP and regulatory standards.

Requirements:

Education & Experience

• Degree: Bachelor's in Science, Tech, Engineering, or a related field.
• Experience: 3-5 years in project management, specifically within clinical data or pharmaceutical R&D.
• Regulatory Knowledge: Experience working with validated systems in a GxP environment.

Technical & Soft Skills

• Methodologies: Familiarity with PMP, PRINCE2, or Agile; PMP/PRINCE2 certification is a plus.
• Tools: Experience with software like MS Project, Jira, or Smartsheet.
• Communication: Ability to explain technical project status to both tech teams and business leaders.
• Problem Solving: A structured approach to managing risks and handling multiple priorities at once.

Nice-to-Haves

• Experience with laboratory information systems or clinical data warehouses.
• Basic knowledge of SQL for data validation.
• Experience with internal audits or regulatory inspections.