Associate Director, GCS Delivery, Solutions Implementation Lead (perm, fix-term, secondment)

Associate Director, GCS Delivery, Solutions Implementation Lead (perm, fix-term,secondment)

Location: Warsaw, hybrid work (3 days from office per week)

Global Clinical Solution (GCS) drives the delivery of Business Technology Excellence for R&D by providing industry leading technology and services in collaboration with internal and external Partners. The Solutions Implementation Lead (SIL) serves as the primary point of contact and business partner for Global Study Teams and other functions, ensuring a seamless connection for all clinical technologies within the scope of GCS.

SILs are accountable for the setup, implementation, and maintenance of Clinical Technologies, providing essential support throughout the study lifecycle. They possess a high degree of expertise in project management frameworks, End-to End (E2E) study management processes, systems, and vendor collaboration. As representatives of the entire GCS team for the study, SILs manage all clinical technologies, ensuring their e􀆯ective deployment and utilization.

Key Responsibilities

• Strategic Technology Support: Acts as the primary business partner for Global Study Teams and other functions, providing technology support and conducting risk assessments.
• Comprehensive Accountability for Clinical Technologies: Manages all clinical technologies utilized in the study, serving as the main point of contact for technologyrelated inquiries and issues.
• Technology Implementation Plan: Develops and executes the Technology Implementation Plan for clinical studies, ensuring alignment with study goals and timelines.
• E2E Process Management: Leads the oversight of end-to-end processes for system integration, user acceptance testing, deployment, maintenance, and closeout.
• Cross-Functional Collaboration: Engages with the Clinical Project Team (CPT), Global Study Management Team, Evinova Team, External Partners and others to implement appropriate technologies.
• Audit and Inspection Support: Leads and participates in activities supporting audit and inspection readiness. Actively participates in audits/regulatory inspections when required and manages Corrective and Preventive Actions (CAPAs).
• Quality and Compliance: Reports and drives the completion of quality issues, ensuring adherence to industry standards and continuous improvement based on feedback.
• Relationship Management: Develops and manages relationships with external technology and service providers, ensuring alignment with study needs and enhancing collaborative efforts.

Candidate Profile:

• Education: University degree (or equivalent) in medical/biological sciences, clinical research, or computer science. Advanced degree preferred.
• Experience: Significant experience in clinical research with demonstrable knowledge of drug development processes or software development processes.
• Technical Skills: Proven expertise in study management processes and systems areas.

Skills and Capabilities

• Excellent Negotiation and Stakeholder Management Skills: Ability to work collaboratively and motivate others to achieve individual and organizational objectives.
• Change Management Skills: Proficiency in change management and championing continuous improvement and innovation.
• Organizational Skills: Demonstrates strong organization and time management capabilities, with attention to detail and decision-making skills.
• Analytical and Strategic Thinking: Exhibits conceptual, analytical, and strategic thinking abilities with a focus on industry transformation needs.