Summary
About the Role
Key Responsibilities:
Contributing SSU insights to the development of the trial Operational Execution Plan (OEP) and aligns the SSU plan and strategy accordingly as reflected in SSU systems, milestones and dashboards with Study Leader/Clinical Trial Team (CTT).
Configuring and ensuring proper trial-specific set-up of SSU systems (e.g., Expected Document Lists, eTMF, milestones, tasks, personnel, vendors, languages/translations, confirmed and back-up countries, CTMS (Clinical Trial Management System), enrollment plan, vendor management tool, site contracting and budgeting tool, ICF template tool, etc.)
Ensuring timely collection global trial level document readiness (including vendor and Investigational Medicinal Product) and collection into eTMF as necessary for country health authority and Ethics Committee submission and site activation.
Supporting the Vendor Program Manager (VPM) as needed to ensure timely global vendor activation and HA submission documents.
Enabling country Study Start-up Managers to drive timely start-up activities from country allocation to “Ready to Enroll” within assigned trial.
Ensuring global deliverables to enable site initiation readiness is in place for initial drug release.
Essential Requirements:
Degree in scientific or health discipline.
Fluency in English (both written and oral).
Experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials.
Contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry or a contract research organization.
Proven ability to effectively engage and lead associates from varying backgrounds and functions within dispersed and highly matrixed organizations.
Excellent communication, influencing and negotiating skills.
Good knowledge of Good Clinical Practice, clinical trial set-up design and global drug development process.
Demonstrated effective influencing and negotiation skills at all levels.
Desirable Requirements:
Advanced degree with clinical trial experience and/or project 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
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.
Accessibility and accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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.
