公司簡介
諾華中國
所屬團隊
職位屬性
- 招聘類型：社招
- 工作性質(zhì)：全職
職位描述
-Monitors patient data & study-related information related to clinical study sites and clinical trial participation.. Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides 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).
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 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
Commitment 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 needed
?Minimum 3 years’ experience in clinical operations in a monitoring / site management role
Desirable Requirements:
?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
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.
任職條件
Clinical Monitoring
Clinical Trials
Collaboration
Data Integrity
Decision Making Skills
Clinical Research
Clinical Trial Management Systems
Clinical Study Reports
Lifesciences
職位要求
- 學(xué)歷要求：無
- 工作經(jīng)驗：經(jīng)驗不限
- 外語要求：不需要