339555BR
Feb 21, 2022
China

Job Description

500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020-
2022. Novartis GDD (Global Drug Development) oversees the development of new medicines
discovered by our researchers and partners. It drives breakthrough innovations to improve and extend
the lives of millions.

Your key responsibilities:
Your responsibilities include, but are not limited to:
· Lead functional activities for a medium to large sized project in phase I to IV clinical studies in Novartis Global Development Organization.
· Co-ordinate activities of Data Managers either internally or externally. Make data Mgmt decisions and propose strategies at study or project level. Ensure application of consistent data Mgmt processes, influence increased standardization and documentation across assigned project/programs
· Comply with company, department and industry standards and processes. Provide and implement data Mgmt solutions; ensure knowledge sharing.
· Leads process and training deliverables within multiple platforms, franchises or therapeutic areasDevelops strategies to ensure effective training and knowledge retention.
· Progresses DO towards complete, compliant, agile and simple end to end processes and effective training (Protocol/Measure through Analysis and Reporting). Drives towards agreed deliverables, proactively addressing potential issues before they become problematic
· Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical data Mgmt aspects. Represents DO in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response. Manages and measures quality
· Coordinates exception requests, deviations and corrective/preventative action plansEnsure timely and quality development/ validation of CRFs and edit specifications for assigned studies/programs Responsible for quality control and audit readiness of all assigned data Mgmt deliverables as well as accuracy and reliability of the clinical database.
· Act as subject matter expert (SME) or, as assigned, lead process improvement/non -clinical project initiatives. Develops risk Mgmt strategies to prevent data quality/coding issues from derailing projects
· Manages effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutions -Represent Data Mgmt at audits and in Health Authority (HA) meetings for assigned project(s)
· Provide Functional/technical Coding leadership for Therapeutic Area/Franchisee having multiple trials or mega trials in the role of Lead Coder ans ensures that Clinical Coding is performed at a consistently high standard.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
· Project Management
· Functional Breadth
· Cross Cultural Experience
· Product Development
· Data Safety Regulatory Strategy Modeling & Simulation

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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: 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, follow us via Novartis Group WeChat Recruitment Account.
Global Drug Development
GDO GDD
China
Shanghai
Research & Development
Full Time
Regular
No
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339555BR

Principal Clinical Data Manager

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