Technology Research Analyst SME providing technical advisory for technology integration in federal environments. Focused on modernization efforts through technology evaluation and validation.
About the role
- Site relationship management role ensuring sustainable trial start-up for assigned sites in clinical drug development at Novartis. Collaborating with global teams and ensuring adherence to clinical operations standards and timelines.
Responsibilities
- Site relationship management role to ensure sustainable trial start-up at Site
- 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)
- 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
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
- 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
Benefits
- N/A
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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