348609BR
Jul 11, 2022
India

Job Description

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Operational and technical management and development of assigned project/ project team. Accountable for all aspects of project delivery within assigned discipline including the
strategy and planning
• Contribute to the definition and lead implementation of the Clinical Data and Reporting
Standards strategy within assigned team/area defining and monitoring metrics and other
indicators of effectiveness and adoption covering quality, timeliness, cost, customer
service and driving continuous improvement.
• Define and monitor robust, priority driven plans foe managing and monitoring resources
within assigned team/discipline to ensure agreed deliverables are met and resources are
fully and effectively utilized.
• Responsible for technical strategies and support for the programmers and analysts within
the data review reporting & analytics group.
• Perform technical investigations and drive technical resolution for any identified issues
and continue to support the strategy and vision for the group.
• Ensure all tools continue to work as appropriate with changes in data governance.
• Drive technical training, mentoring and educations around the contents and use of tools.
• Be the technical SME for data review and reporting and related queries
• Ensuring alignment with the CDS strategy:
• Responsible for Clinical Data Standard/automation solution planning, definition,
development, validation and support
• Serves as the primary contact for global / TA data standards and/or technologies ensuring
timely and quality deliverables..
• Responsible for driving efficient, high quality and timely implementation of new standards
and/or technologies.
• Ensure efficient governance and approval of global clinical data standards / technologies
liaising with governance boards as needed.
• Lead the technical review and assessment of industry and regulatory standards and
technologies supporting regular gap/impact analysis and implementation of action plans
where needed.
• Lead and contribute to the development, maintenance and training of relevant clinical
standards systems and processes.
• Act as an expert consultant providing Clinical Data Standards input to all relevant areas
including; electronic data capture/database programming, edit check programming, report
programming, electronic data loads, IVR technology, electronic patient reported outcomes,
metadata management and/or other clinical data management or analysis data and
TFL-related systems.
• Act as primary subject matter expert (SME) for assigned area providing support,
consultation and training to end users and SME networks on implementation of standards and
related tools on development programs.
• Provide mentoring and technical guidance to Clinical Data Standards associates;
• Contributes to the effectiveness and development of talent.

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 with 12-15 years experience in Clinical Data Standards
• Strong leadership, collaboration and organizational skills with proven ability to successfully manage numerous, simultaneous submissions/projects/trials across multiple Therapeutic Areas and meet deadlines
• Proven ability to anticipate challenges and risks and proactively implement solutions.
• Ability to work under pressure demonstrating agility through effective and innovative leadership
• Excellent analytical, problem solving and time management skills. Excellent interpersonal skills and proven ability to operate effectively in a complex global environment. Ability to influence and communicate across functions and to external stakeholders
• Proven associate development skills. Proven ability to build effective teams that deliver towards the goals of the Data Operations organization
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
Mumbai
Research & Development
Full Time
Regular
No
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348609BR

Associate Director, Clin Data Stds

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