摘要
About the Role
Major Accountabilities
- Perform eligibility assessment, registration, maintenance and results disclosure for assigned clinical studies on public registries such as clinicaltrials.gov according to internal and external requirements.
- Ensure study data/information (protocol, CSR) is accurately represented and maintained on public registries.
- Collaborate with clinical teams (such as Study Leads, M.D.s, Medical Writers, Statistical Programmers, IP attorneys) to align on all aspects related to disclosure.
- Organize and conduct routine client trainings on CDO processes.
- Contribute to the redesign and maintenance of Standard Operating Procedures and training materials.
Requirements
- University or college degree (BSc) in Life Sciences, Natural Sciences, Statistics, Medical Informatics or equivalent long-term professional experience
- Minimum 3 years of experiences in clinical trial disclosure with significant experience related to the conduct and analysis of clinical trials
- Advanced understanding of global legislations, regulations and guidelines
- Knowledge of Good Clinical Practice (GCP) regulations
- Flexible, willingness to adapt, willing to speak-up and challenge
- Experience in developing effective working relationships with internal and external stakeholders
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? : http://www.novartis.com/about/strategy/people-and-culture
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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: http://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? http://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: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
