Manager Study Governance

Job Description

Role Overview: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 organization.Key Responsibilities:- Maintain and enhance Novartis standards and manage the development of internal and external policies, guidelines, procedures, systems, and tools for NIS, Registries, IITs, IIR, LIS, and RCs in line with international guidelines and regulations.- 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.Qualification Required:- Masters 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. Role Overview: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 organization.Key Responsibilities:- Maintain and enhance Novartis standards and manage the development of internal and external policies, guidelines, procedures, systems, and tools for NIS, Registries, IITs, IIR, LIS, and RCs in line with international guidelines and regulations.- 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 se

Keyskills :
GovernanceRisk MitigationLegalEthicsComplianceInternal AuditQuality AssurancePatient SafetyTrainingChange ManagementQualityCommunication SkillsPatient Centricity