Study Start-Up CRA

Shanghai, China
Closing date
Jun 10, 2023

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Full Time
Organization Type
Jobseeker Type
Job Description

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine - imagine the impact you could have as SSO Study Start-Up CRA!

Site relationship management role to ensure sustainable trial start-up at Site.

The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs.

Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).

Location: Open to All Cities in China
Position Number: 10

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager. Collaborates with SSO Study Start-Up Manager, SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments
• Accountable for timely start-up activities from country allocation until site greenlight at assigned sites. Conducts site selection visits, verifies site eligibility for a specific study. Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
• Ensures that milestones (KPIs) and time schedule for study start-up are met as planned. Facilitates the preparation and collection of site and country level documents. Collects submission relevant site-specific documents (e.g., FD, CV, GCP certificates, DSL...) for all relevant site personnel within agreed timelines
• Supports SSU Manager in preparation of country-specific documents, e.g., ICF, patient facing materials, etc. Supports SSO Study Start-Up Manager and assigned sites in vendor set-up activities. Prepare and finalize site specific documents for submission
• Negotiates investigator payments as needed. Supports preparation of financial contracts between Novartis and investigational sites and investigators as needed
• Updates all systems until site Green Light on an ongoing basis. Supports preparation of audits and inspections as applicable. Supports reduction of formal site-specific IRB/IEC deficiencies
• Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness. Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
Implements innovative and efficient processes which are in line with Novartis strategy. Ensures sites are prepared for “Green Light” and is accountable to send the Green Light to SSU Manager for review and approval

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 role:
• A degree in scientific or health discipline, preferably with clinical operations experience (or, for United States: 4-year degree plus relevant, related healthcare experience)
Fluent in both written and spoken English, local language as needed
• Minimum 3 years’ experience in clinical operations in a monitoring / site management role. Advanced understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring. Central/in-house monitoring or field monitoring experience is desirable
• Strong site management capabilities with demonstrated negotiating and problem-solving skills. Advanced understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
• Strong interpersonal, negotiation and conflict resolution skills. Ability to travel, e.g., for site selections, if applicable
• Ability to manage multiple priorities and manage time efficiently
• Fast change adaptability to best partner & influencing with sites on fast changing landscape
• Trust and rapport building is a very important skill needed. Good communication skills, ability to influence others & Relationship management


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!

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message
诺华承诺与残障人士共事并为他们提供合理的便利设施.如果您由于健康状况或残障,在招聘过程的任何环节需要合理便利设施,或者为了履行职位的基本职能,请发送电子邮件至 [email protected] ,告知您的需求和联系方式,并在邮件中附上您的职位申请编号.

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:

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