Senior Global Process Owner - Study & Site Management

As Senior Global Process Owner (Sr. GPO) you will have significant impact and accountability for designing and managing an end-to-end business process that is compliant with regulatory requirements and is fulfilling business needs across the end-to-end clinical trial process in Novartis drug Development.

The role drives adoption by working collaboratively with Global Line Functions, within a complex matrix, ensuring that processes meet both high design standards, regulatory compliance, and high levels of practicality. You will be an advocate for simplification and process automation.

Hiring Requirements:

The Sr GPO will be responsible for overall governance and oversight of a process by setting appropriate strategy, coordinating process mapping activities, overseeing the development the various procedural documents related to a process, ensuring efficiency and effectiveness of the process and managing risks. In addition, the Sr GPO would also be responsible to monitor process performance via KPIs/KQIs aligned with regulatory and organizational strategies.  

Major accountabilities:

1. End‑to‑End Process Ownership & Strategy

• Accountable for the overall design, delivery, maintenance, and continuous improvement of the designated process(es).
• Lead long‑term process strategy, ensuring alignment with regulatory expectations and business needs.
• Anticipate internal/external changes and assess their impact on processes and supporting systems.

2. Cross‑Functional Collaboration & Process Improvement

• Lead and support cross‑functional process improvement and change‑management initiatives.
• Drive simplification, automation, and standardization across functions.
• Ensure transformed processes can be executed globally by responsible line functions.

3. Governance, Documentation Oversight & Compliance

• Ensure oversight and lifecycle management of controlled documents (SOPs, WPs, manuals) for the process.

• Ensure coherence and harmonization across procedural documents within the process.
• Oversee process‑related risks and ensure appropriate mitigation strategies.
• Monitor performance trends, conduct root cause analysis/FMEAs when needed, and ensure appropriate risk management.

Minimum Requirements:

Education: University degree in Life Science, quantitative science or business. Desirable qualifications in shared services, outsourcing, global sourcing. project management/Coaching, 6-Sigma, Lean education/training, Master of Business Administration or equivalent 

Work Experience:

• Extensive knowledge of end-to-end processes within clinical development, including supporting systems, regulations, and awareness of business changes.
• 5 years' Site Management, Clinical Trial Monitoring, CRA Management and/or Clinical Project Management (Country level) domain experience essential.
• Ability to anticipate and assess the impact of external and internal changes on the end-to-end process, supporting systems (and vice-versa), and associated training requirements. 
• Experience in effective process improvement.
• Strategic thinker with the ability to contribute to long-term process improvements and operational planning. 
• Experience with process simplification and optimization, including improvements to quality documentation. 
• Demonstrated ability to collaborate effectively across functions, supporting performance improvements within the end-to-end clinical development value chain.