Principal Clinical Data Manager

324231BR
Jul 27, 2021
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:

• Provides Data Management leadership for one or more assigned programs or indications.
Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i:e ensuring consistency across data quality plans
• Develops an understanding of CDISC or other recognized industry standards and how these impact the programming team. Ensures consistency of program level standards
• Communicates and negotiates effectively with all other Program level team members. Primary point of contact for DM at the GPT level
• Maintains awareness of the status of start up, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Demonstrates an effective application of knowledge across all DM scenarios. Is able to provide solutions to effectively meet timelines
• Manages effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutions
• Supervises and drives the overall DM timelines across assigned programs. Reviews the Data Management Metrics on the assigned Program. Coaches and mentors associates as required, ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution.
• Develops risk management strategies to prevent data quality issues from derailing projects
• Represents Data Management at cross functional forums, meetings and provides timely feedback to partners. Understands Health Authority requirements and is able to prepare for and participate in Health Authority inspections and audits as required

Minimum Requirements

• University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree with Ideally 8 years’ experience in Drug Development with at least 5+ years' in Clinical Data Management
• Strong leadership, collaboration and organizational skills with proven ability to successfully manage simultaneous trials and meet deadlines
• Excellent understanding of clinical trials methodology, GCP and medical terminology
• Must be able to anticipate challenges and risks and proactively suggest/implement solutions
• Ability to work under pressure demonstrating agility through effective and innovative team leadership
• Excellent interpersonal skills and proven ability to operate effectively in a global environment. Ability to influence and communicate across functions and to external stakeholders
• Understanding of project management concepts in order to aid delivery across a program

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, 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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324231BR

Principal Clinical Data Manager

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