Summary
About the Role
Key Responsibilities:
• Provides DM leadership across assigned trial(s) Acts as the Trial Data Manager where needed
• Demonstrates a business understanding of the compound(s) profile to identify and assist in successful application of data management processes
• Provides feedback to assure well written protocols and amendments. Recognize and resolve protocol issues that may impact database design, data validation and/or analysis/reporting and that do not make the best use of available standards
• Performs DM activities for start up of a study including preparing the eCRF, CCG’s where needed, Data Handling plan (DHP), Data Review Plan (DRP) and performing user acceptance testing (UAT)
• Manage local lab set up for the Clinical Database as applicable. Performs DM hands on activities during the course of the study. Disseminates study level information to the Clinical Trial Team (CTT) and Program Clinical Data Manager (PCDM)
• Responsible and accountable to ensure consistency of assigned trials with program level standards across DM documentation. Supports and assists Junior staff for assigned trials. Ensures Third party and other necessary reconciliation activities are performed for the study in a timely manner
• Provides effective input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence.Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks). Ensures adherence to GCP, DM standards, SOPs/WPS and process guidelines
Commitment to Diversity and Inclusion / EEO:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Essential Requirements:
• Bachelor Degree and above
• Fluent English (oral and written)
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
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to diversityandincl.china@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. You can follow us via Novartis Group Recruitment WeChat Official Account and Novartis Group WeChat Video Account.
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
无障碍及便利 设 施
诺华 承 诺 与残障人士共事并 为 他 们 提供合理的便利 设 施。如果您由于健康状况或残障 在招聘 过 程的任何 环 节 需要合理便利 设 施 或者 为 了履行 职 位的基本 职 能 请发 送 电 子 邮 件至 [email protected] 告知您的需求和 联 系方式,并在 邮 件中附上您的 职 位申 请编 号。