Manager Study Governance

Job Description Summary

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.

Job Description

Manager Study Governance

Location – Hyderabad #LI Hybrid

About the Role:

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.

Commitment to Diversity & Inclusion:

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

Essential 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.

Desirable Requirements

• External orientation and awareness of industry trends.

• Excellence in designing and continuously improving business processes to meet quality and compliance standards and simplify ways of working.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us Learn more here:

You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

Skills Desired

Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Internal Medicine, Job Description, Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)

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