About the role:
Provides comprehensive expertise in support of clinical studies, or leading a clinical study ensuring, consistent and high quality generation of specification, production, and validation of clinical data collection systems and associated metadata with high quality, on time, and within budget in accordance with project budgets. Interpret data collection requirements into data models and uses relevant programming language to build EDC & warehouse setup.
• Provide local technical leadership and expertise from Biologics and Cell&Gene Therapy (Bx&CGT) pharmaceutical development space to support China development portfolio and marketed products
• Serves in a support roles on multiple studies or as a lead for a study (with supervision/ mentoring)
a.Leads the effective and timely development and implementation of clinical systems for assigned studies.
b.Uses database programming techniques to create study specific validations
c.Understand and copy/create study level metadata to compliment data provisioning in compliance with global standards.
d.Develops database and conducts database testing.
e.Develops data models to support data review and acquisition standards to adapt for study/project level needs and specificities.
• Establishes and maintains working relationships with Data Operations.
• Acts as a technical consultant ensuring appropriate development, maintenance, and use of all system capabilities such as electronic data capture, database programming, edit check programming, report programming, electronic data load, interactive response technology, electronic patient reported outcomes, metadata management and other clinical database development activities.
• Ensures that systems meet regulatory requirements, internal standards and are deployed with quality.
• Participate in improvement initiatives and/or non-clinical projects.
• Communicate and ensure that study objectives and priorities are met according to agreed timelines, strategies, quality and scientific standards.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
• Bachelor’s degree preferably in computer science, management information systems, or other related area.
• At least 2 years of experience in setup of clinical databases/Data Warehouse using RAVE or OC-RDC or LSH. Excellent interpersonal and written and oral communication skills, with the ability to effectively communicate cross-functionally
• Advanced technical skills; Good knowledge of EDC - Medidata RAVE preferred. Excellent understanding of relational databases; Microsoft Office Suite
• Knowledge of other programming languages such as SQL, PL/SQL, VBscript, SAS, C# or Java preferred
• Demonstrated ability to consistently produce detailed, high quality deliverables in a team environment
• Good problem-solving, negotiation and conflict resolution skills; Good understanding of Drug Development Process, ICH--GCP and Health Authority Guidelines & Regulations
• Ability to effectively support and contribute to initiatives requiring Clinical Database acquisition tools and design expertise
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 [email protected] 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.