Senior Global Process Owner Study & Site Management

Job Description Summary

Job Description

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 addition the Sr GPO would also be responsible to monitor process performance via KPIs/KQIs aligned with regulatory and organizational strategies.

Major accountabilities:

1. EndtoEnd Process Ownership & Strategy

• Accountable for the overall design delivery maintenance and continuous improvement of the designated process(es).

• Lead longterm process strategy ensuring alignment with regulatory expectations and business needs.

• Anticipate internal/external changes and assess their impact on processes and supporting systems.

2. CrossFunctional Collaboration & Process Improvement

• Lead and support crossfunctional process improvement and changemanagement 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 processrelated 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.

Skills Desired