Hybrid Manager, Study Governance

at Novartis

• Job title: Manager, Study Governance
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Professional Certificate
• Location requirements: Hybrid, Barcelona, Spain

About the role

• Manager at Novartis ensuring governance across Non-Interventional Studies and Investigator Initiated Trials. Collaborating with various functions to uphold standards and mitigate risks.

Responsibilities

• Join Novartis as Manager, Study Governance and play a crucial role in maintaining and enhancing standards, policies, guidelines, processes, systems, and tools for Non-Interventional Studies (NIS), Registries, Investigator Initiated Trials (IITs), Investigator Initiated Research (IIR), Local Interventional Studies (LIS), and Research Collaborations (RCs).
• You will implement risk mitigation plans in close collaboration with Legal, Ethics Risk & Compliance, Internal Audit, Quality Assurance, and Patient Safety, ensuring robust governance and continuous improvement across the organisation.
• Facilitate correct implementation of standards and tools at country organisations and global functions, providing enterprise-wide central governance and oversight.
• Actively contribute to continuous improvement for assigned processes, products, and services, participating in cross-functional projects to simplify and improve adherence.
• Demonstrate and act according to Novartis values and behaviours, supporting a culture of inspiration, curiosity, and self-awareness.
• Support the development and delivery of training for associates and management to ensure adherence to standards, promoting collaboration through education and learning opportunities.
• Identify quality and compliance risks for Novartis in assigned areas and establish mechanisms to mitigate these risks.
• Promote change management and support a culture of quality, compliance, and patient centricity, identifying opportunities for global/local alignment.
• Maintain and enhance internal controls to measure compliance, review audit outcomes, and support country self-assessments based on defined control matrices.
• Maintain effective communication channels with Novartis teams and present to management as requested.
• Support country organisations in setting up and executing corrective and preventive action plans in response to audit or inspection findings.

Requirements

• Master’s degree in science; Doctor of Medicine (M.D.) or Pharm D. is a plus.
• Approximately 5 years’ relevant work experience within clinical settings, public health, or the pharmaceutical industry (e.g., medical affairs, drug development, patient safety, quality, or compliance).
• Strong technical knowledge in governance areas relevant to the role.
• Excellent interpersonal skills, demonstrating collaboration, quality, and integrity; ability to bridge scientific and business experts.
• Experience working in matrix teams in global organisations and project teams.
• High learning agility, comfortable with complexity and diversity, and a strong interest in continuous improvement.
• Excellent communication skills across different audiences and organisational levels.
• Excellent English language skills, both written and spoken.

Benefits

• Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.