Clinical Operations Excellence Manager

Purpose

Responsible for supporting the streamlining, monitoring, and continuous improvement of GCO processes and procedures to enhance efficiency and inspection readiness.

Contributes to the identification and implementation of optimal technological infrastructures, ensuring the effective integration of selected e-platforms and vendors with GCO processes, the Chiesi portfolio, and the future strategic evolution of clinical operations.

Supports the technical maintenance, monitoring, and continuous improvement of an effective operational and partnership model within GCO, fostering a sustainable and future-proof vendor management approach aligned with Chiesi’s portfolio and long-term strategic vision.

Main Responsibilities

Management:
•    Lead the assessment and technical implementation of current and new processes/procedures within GCO, focusing on the revision of the operational model to identify opportunities and drive solutions that improve efficiencies across related functional areas.
•    Develop mechanisms to monitor workstream progress and facilitate intervention and problem-solving with internal stakeholders.
•    Apply diagnostic expertise proactively to analyze and identify potential process improvements.
•    Evaluate process issues and develop resolutions to meet productivity, quality, and stakeholder satisfaction goals (both internal and external).
•    Innovate, integrate, and manage communication strategies within GCO (and GCD where applicable), securing support for change and overcoming obstacles that may hinder the implementation of new initiatives.
•    Monitor and analyze external Clinical Operations trends, guidelines, and policies to ensure compliance, efficiency, and provide strategic recommendations to the organization.
•    Collaborate with GCO/GCD leadership and workstreams to identify opportunities for sharing best practices and developing enterprise-level solutions that create value and support talent development.
•    Lead the identification of optimal technological infrastructure to leverage the growing external offer of solutions, focusing on vendors working across various programs (e.g., providing spirometry, e-diaries, AI) and integrated e-platforms.
•    Oversee Third-Party vendors’ setup activities, timelines, and performance to ensure alignment with company standard operating procedures, study protocols, and company objectives.
•    Implement processes, coordinate rollouts, and conduct training activities to ensure organizational preparedness—including data transparency and inspection readiness—related to the operational model and implemented technologies.
•    Collaborate with internal and external stakeholders to leverage best practices, technology, and expert knowledge.
•    Foster a culture of continuous improvement, setting high performance standards, focusing on exceeding objectives, and promoting outstanding cross-functional collaboration while identifying and nurturing talent.
•    Create and maintain an inclusive and respectful work environment that embraces diversity, encourages innovation, and promotes a secure and positive atmosphere.
•    Support the implementation and continuous development of a revised operational model within GCO, maintaining strong relationships with CROs/vendors to ensure a collaborative and productive partnership.
Quality / Excellence:
•    Implement best practices and maintain consistency of standards for study and program management, in collaboration with other clinical operations team members, including the establishment and maintenance of Clinical Operations-specific SOPs.
•    Ensure that the engagement operations organization and infrastructure are fit for purpose and meet expected clinical trial excellence standards.
•    Provide clinical and operational expertise/guidance for all supervised activities.
•    Act as the primary point of contact for audit and inspection activities, ensuring that the organization adheres to the highest standards of operational excellence and regulatory compliance within evolving scientific and regulatory environments.

Experience Required

At least 5 years of experience in clinical trial operations as CPM role or as clinical responsible manager, with proven experience with processes and procedures.
Proven experience in vendor management within the clinical research or pharmaceutical industry (CROs, central labs, imaging vendors, eCoA etc.).

Education

Bachelor's degree or equivalent in appropriate scientific or business disciplines,  familiar with relevant ICH/GCP, EU and FDA guidelines and SOPs.

Languages

Fluency in english

Technical Skills

Excellent knowledge of healthcare compliance and other relevant guidance.

Excellent knowledge of the clinical trials settings.

Excellent project management capabilities with demonstrated capability to problem solve and mediate complex issues.

Understands financial procedures, budget management.

Soft Skills