353853BR
Sep 27, 2022
India

Job Description

500 studies across multiple therapeutic areas. This is the exposure and scale our Data Management group has. We are on our journey to Reimagine medicine with Data and Digital and our team is focused on delivering data which is fit for purpose.
Innovation at scale is one of the strategic pillars for us as a Clinical Data Management team and you will have an opportunity to apply your skills to experiment and innovate ways to transform the Clinical Data Management process in Drug Development.
We are looking for individuals with end to end experience in clinical data management. You will play a key role in providing leadership to various teams and developing cross-functional data cleaning strategies.

Your key responsibilities:
Your responsibilities include, but are not limited to:

• As Clinical Data Manager (CDM) provide data management input on Clinical Trial teams. May have the role of TDM on small low complexity trials . 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) as applicable
• Manage local lab set up for the Clinical Database as applicable
• Under supervision ensures consistency of assigned trials with program level standards
• Understands third party data requirements and begins to gather an understanding of new technologies that may be used in the course of clinical trials
• Performs ongoing review of all data generated from the clinical study including Third party and local lab data as well as SAE reconciliation where applicable
• Ensures activities that are performed are done with quality and understanding of the process. Verifies and tracks eCRF completion including Query resolution and provides data status updates as needed
• With support from the Trial Data Manager develops proposals to resolve issues that may occur during the running of assigned trials. With support from the Trial Data Manager gives input into Study Specification worksheets should assigned trials need to be outsourced
• Has a working knowledge of FDA and ICH guidelines. Has proven ability to use the tools available to generate listings for data review and where necessary provides these to the study teams. Generates the study status reports for use at Clinical trial team meetings

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

• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
• Fluent English (oral and written).
• Strong technical skills,
• Fluent English verbal and written
• Ideally 3 years experience in Drug Development with at least 2 years in Clinical Data Management

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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 teams 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, join the Novartis Network here: https://talentnetwork.novartis.com/network
Global Drug Development
GDO GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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353853BR

Clinical Data Manager

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