Sammendrag
About the Role
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 results 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 achievements (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 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
Essential Requirements
- A degree or equivalent experience in scientific or health subject area, preferably with clinical operations experience
- Proven experience in clinical operations in a monitoring / site management role
- 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 proven negotiating and problem-solving skills. Understanding of the international aspects of drug development process, includincluding significantedge of international standards. Strong interpersonal, negotiation and conflict resolution skills.
- Ability to travel, e.g., for site selections, if applicable. Ability to handle multiple priorities and manage time efficiently. Fast change adaptability to best partner & influencing with sites on constantly evolving landscape.
- Trust and rapport building is a very important skill needed. Good communication skills, ability to influence others. Relationship management
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
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: https://talentnetwork.novartis.com/network
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
