Key Responsibilities：
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 ManagerCollaborates 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 commitmentsAccountable for timely start-up activities from country allocation until site greenlight at assigned sitesConducts site selection visits, verifies site eligibility for a specific studyMain contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparationEnsures that milestones (KPIs) and time schedule for study start-up are met as plannedFacilitates the preparation and collection of site and country level documentsCollects submission relevant site-specific documents (e.g., FD, CV, GCP certificates, DSL...) for all relevant site personnel within agreed timelinesSupports 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 activitiesPrepare and finalize site specific documents for submissionNegotiates investigator payments as neededSupports preparation of financial contracts between Novartis and investigational sites and investigators as neededUpdates all systems until site Green Light on an ongoing basisSupports preparation of audits and inspections as applicableSupports reduction of formal site-specific IRB/IEC deficienciesEnsures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readinessEnsures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirementsImplements innovative and efficient processes which are in line with Novartis strategyEnsures sites are prepared for “Green Light” and is accountable to send the Green Light to SSU Manager for review and approvalCommitment to Diversity and Inclusion / EEO:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Essential Requirements:
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 neededMinimum 3 years’ experience in clinical operations in a monitoring / site management roleDesirable Requirements:
Advanced understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoringCentral/in-house monitoring or field monitoring experience is desirable
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining
to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
Benefits and Rewards: Go to Novartis career website to learn about all the ways we’ll help you thrive personally and professionally.
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 tell your relevant request to our hiring managers.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up. You can follow us via the official account and video account of Novartis Recruitment.
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up. You can follow us via social media account of Novartis Recruitment.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division Development Business Unit Innovative Medicines Location China Site Beijing (Beijing) Company / Legal Entity CN06 (FCRS = CN006) Beijing Novartis Pharma Co., Ltd Functional Area Research & Development Job Type Full time Employment Type 正式 Shift Work No Apply to Job 无障碍及便利 设 施诺华 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。
iframe{ width: 100%; margin-top: 3rem; } @media screen and (max-width: 767px){ iframe{ height: 30vh !important; } } @media screen and (min-width: 768px){ iframe{ height: 34vh !important; } } Job ID REQ-10032137 Global Clinical Operations- Study Start-Up CRA Apply to Job