Summary

Fixed term - 2 years contract
Location: Budapest, Hungary.
Hybrid #hybrid

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. This is a field position and will require ability to travel to sites throughout the country.

About the Role

Accountabilities

• 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

• Externally facing role with impact on Principal Investigators and Institution/Site business offices.
• External engagements with vendor partners to lead site issue resolution as needed.
• Partners with execution Clinical Research Associate to ensure seamless transition of site responsibility at time of site initiation

• A degree in scientific or health discipline, preferably with clinical operations experience

• Fluent Hungarian and Fluent in both written and spoken English

• 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