CRA -BJ

Research & Development       ·        Beijing, China          ·      Full time

Job ID: 354444BR

Job Title: CRA -BJ

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;
• Is 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. Is 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.

Commitment to Diversity & Inclusion:

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 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; Monitoring experience is desirable
• Good knowledge of drug development process specifically clinical trial/research; Knowledge of international standards (GCP/ICH, FDA, EMEA)
• Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings; 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.
• Good communication skills, ability to influence others; Good strategic thinking.

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

While Novartis does not require vaccination for Covid-19 or proof of a recent negative test result for Covid-19 at this time, employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com.

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: https://talentnetwork.novartis.com/network (https://talentnetwork.novartis.com/network).

Division: NIBR
Business Unit: GDO GDD
Country: China
Work Location: Beijing
Company/Legal Entity: CNIBR Co. Ltd.
Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
Shift Work: No
Early Talent: No

Please click here to apply.