May 05, 2022

Job Description

500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020-2022. Novartis GDD (Global Drug Development) oversees the development of new medicines discovered by our researchers and partners. It drives breakthrough innovations to improve and extend the lives of millions.

Your key responsibilities:
• Site Quality Check (site QC)
- Work with CSM groups to develop country annual site Quality Check plan, by identifying priority trials and sites with high risk.
- Prior to site QC visit, have meeting with CSM and site CRA to discuss trial protocol and site status. Conduct off-site check for CRA training records and c/s-TMF.
- During site QC, check Investigator Site Folder, trial records and source documents, IMP and sample management, and etc. And document all GCP compliance observations.
- Discuss with CSM and site CRA about all GCP compliance observations.
- Discuss with investigators if any observations are related to the investigator responsibilities.
- Draft QC report and send to CSM and site CRA for responding with action plan (CAPA).
- Discuss with CSM and site CRA to finalize the CAPA and QC report.
• Inspection Preparation
- Support CSMs to conduct site QC for inspection preparation
- Provide results to CSMs, and support action plan development and risk assessment
- Provide on-site support during inspection, and support CAPA development after inspection
• Process compliance check (process QC)
- Work with regional Process Control Manager and process SME to develop country annual process compliance check plan, by identifying processes with high risk.
- Conduct process QC by reviewing related records against requirements of SOP and/or regulations to assess the process compliance status
- Complete process QC report; provide feedback on process compliance and enhance process implementation
• Perform trend analysis of identified quality and process compliance observations.
• Provide advice on CAPA generation for QC/audit/inspection, and follow up the action owner to ensure CAPA completeness.
• Provide quality related training to TMO associates.
• Lead quality improvement initiatives.
• (when applicable) Provide support on team management of GCP Compliance associates.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:
• Advanced Degree or equivalent education/degree in life science/healthcare required; Fluent in both written and spoken English.
• 5-6 years working experience and good knowledge of the clinical operation process. Minimum 4 years’ experience as a Clinical Research Associate, with proven excellence and experience in all aspects of monitoring and site management. 1-2 years GCP QC experience is required.
• Project management skill is required. Knowledge of Instructional Design/Adult Learning Principals.
• Well-developed communication skills and the ability to write and present concise, accurate reports and other necessary documentation.
• Ability to follow up on multiple tasks and projects, and to handle confidential information diplomatically. Ability to travel domestically as needed to study sites and for training and meetings. A minimum of 50% overnight travel may be required.

Desirable requirements:
• People management experience is preferred.
• Excellent knowledge, understanding and experience of GCP and international, national and local regulations and laws related to clinical trials. Excellent communication and presentation skills.

Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
Research & Development
Full Time
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Clinical Compliance Manager

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