Manager, Clinical Process

5 dni temu

Warszawa, Mazovia, Polska Alimentiv Inc. Pełny etat

The Manager, Process & Training Center of Excellence (PTCoE) will champion operational excellence and drive continuous process optimization within Alimentiv's service delivery, focusing on increasing trial efficiency, speed to delivery, and quality for our sponsors. This role will drive PTCoE strategy to lower overhead and resource costs; increase accountability in day-to-day work; support a scalable process architecture for future growth & technology adoption, enhance nimbleness in our processes, and increase the quality of deliverables.

Service Delivery & Operations
  • Develop, oversee, and maintain process architecture through Value Stream and Process Mapping.
  • Measure process effectiveness through KPIs and metrics to ensure they meet business objectives. Understand and integrate industry benchmarks where appropriate.
  • Review KPIs and/or conduct detailed analysis of current business processes to identify inefficiencies and areas for improvement.
  • Collaborate with cross-functional teams to understand their process needs; advise and support appropriate changes and updates and ensure successful implementation of process changes.
  • Support process development for clinical system implementations.
  • Support process management and development within service delivery departments and teams. Ensure process standards and requirements are met in the update and development of processes prior to QMS submission.
  • Lead and/or execute change management & training strategies to support process enhancements.
  • Support strategic sponsor partnerships bridging processes.
  • Work with Quality Assurance and HR to develop an organizational training framework, assess training gaps and create organizational plans to fill gaps.
  • Lead and/or oversee the development of clinical research professional development training initiatives and programs.
  • The PTCoE will oversee the development of role-specific training curricula and delivery of training, both general and role-specific, to employees on new processes and supporting tools.
  • Provide training and leadership in process development, management, and PDAC cycle.
  • Liaise with Quality Assurance to align on QMS strategy, framework, and expectations and drive expectations throughout the service delivery team.
  • Develop Process Governance ensuring processes are aligned with strategic goals.
  • Ensure process standards and requirements are met in the update and development of processes prior to QMS submission.
Continuous Improvement
  • Enable a quality culture by driving the continuous process improvement cycle within CLS.
  • Prepare and present detailed reports on process improvement initiatives and outcomes.
  • Stay up to date with industry trends, regulations, and best practices and adopt these within service process improvement.
Qualifications
  • A minimum of a Bachelor's Degree with 4-6 years of related experience.
  • Strong communication and relationship building skills.
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