Summary
Hybrid
As Senior Global Process Owner for Study & Site Management you will own the end‑to‑end, regulatory‑compliant study and site process, strengthening its health and maturity through continuous improvement, and powering faster, quality‑driven clinical delivery that gets transformative medicines to patients sooner.
The Senior Global Process Owner for Study & Site Management acts as a single point of ownership that drives process health and continuous improvement for sustained process maturity.
About the Role
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.
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