342702BR
Apr 01, 2022
China

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:
Your responsibilities include, but are not limited to:
 Allocation, initiation and conduct of trials:
- Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial. Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
- Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
- Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate. Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
- Accountable for continuously updating all electronic systems (global and local) relevant to perform job functions. Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.). Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements. Attends onboarding, disease indication and project specific training and general CRA training as required. Documents monitoring activities appropriately following Novartis standards
- Collaborates with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as needed

 Delivery of quality data and compliance to quality standards
- Monitors studies as per current legislations, ICH/GCP and Novartis standards. Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring. (ADIS, DBL). Identifies issues at sites; resolves issues and escalate as appropriate
- Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry. Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep sTMF(s) current.
- Supports the implementation of innovative processes and technologies

 Budget and productivity
- Negotiates investigator remuneration; prepares financial contracts between Novartis and investigational sites and investigators. Ensures that payments are appropriately triggered to investigational sites

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the job:
 Degree in scientific or healthcare discipline.
 Fluent in both written and spoken English, local language as needed in clusters/countries.
 Up to 2 years pharmaceutical industry experience or other relevant experience
 Good knowledge of drug development process specifically clinical trial/research. Knowledge of international standards (GCP/ICH, FDA, EMEA)
 Monitoring experience is desirable
 Good communication skills, ability to influence others. Excellent communicator and presenter (oral and written), ability to communicate to Sr. Leaders
 Ability to manage sites independently; Proven ability to work independently with minimal supervision. Ability to anticipate potential issues and take appropriate actions with or without supervision.
 Advanced data accuracy: Ability to work focused with a great attention to detail


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
GDO GDD
China
Chengdu
Research & Development
Full Time
Regular
No
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342702BR

CRA

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