338268BR
Feb 07, 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:
· 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

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:
· University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
· 3-5 years experience in Data Management
· Strong technical skills,
· Fuent English verbal and written
· Basic knowledge of the Drug Development and Clinical Data Management processes


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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338268BR

Senior Clinical Data Manager

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