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Job details
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NATURE OF JOB
Hybrid — WFH / WFO / CW
- CATEGORY Programming
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SALARY RANGE
Best in the industry Annual
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EXPERIENCE
1 – 3 Years
- JOB TYPE Full Time
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REGIONAL PREFRENCES
India
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NO. OF VACANCIES
1
Job description
Job Description
< u>< strong>100,000 and more!
That’s how many patients are treated in our studies. And every year, 3 million documents are uploaded in the electronic Trial Master Files to preserve the story of the study and ensure innovative medicines can reach even more patients worldwide. But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.
The CDM Techology group is accountable for implementing and embedding document management systems, technologies and tools aligned and harmonised across business units enabling Novartis to meet its sponsor obligations on consistent, quality, readily accessible, inspection ready and available essential documentation in the shape of a Trial Master File (TMF) for human subject research studies.
The Director, CDM Technology will drive the tactical implementation of the Clinical Document Governance & Management strategy to meet immediate needs and evaluate future strategies to build on, ensuring Novartis is in a strong position to deliver TMF for all studies in a simple, consistent, sustainable way in alignment with international regulatory expectations.
Your responsibilities include, but are not limited to:
< u>< strong>100,000 and more!
That’s how many patients are treated in our studies. And every year, 3 million documents are uploaded in the electronic Trial Master Files to preserve the story of the study and ensure innovative medicines can reach even more patients worldwide. But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.
The CDM Techology group is accountable for implementing and embedding document management systems, technologies and tools aligned and harmonised across business units enabling Novartis to meet its sponsor obligations on consistent, quality, readily accessible, inspection ready and available essential documentation in the shape of a Trial Master File (TMF) for human subject research studies.
The Director, CDM Technology will drive the tactical implementation of the Clinical Document Governance & Management strategy to meet immediate needs and evaluate future strategies to build on, ensuring Novartis is in a strong position to deliver TMF for all studies in a simple, consistent, sustainable way in alignment with international regulatory expectations.
Your responsibilities include, but are not limited to:
- Leads the delivery of innovative and efficient operational support for the assigned unit(s); Responsible for strategy Implementation< li>
- Responsible for initiating and driving critical programs and initiatives within own team and or matrix community< li>
- Leads operational excellence initiatives. Drives continuous improvement and provides deep insight with collaborators within area of expertise< li>
- Liaises with other areas of the business providing senior input and advice to global projects. Acts independently to determine methods and procedures on new or special projects assignments.< li>
- Leads and works with own team to build scientific technical expertise. Contributes to long‐term talent and succession planning< li>
- Responsible for initiating and driving critical programs and initiatives within own team< li>
- Accountable for success of project goals, cross‐divisional and or external collaborations within direct and indirect team
< li> < ul> Minimum Requirements
< u>< strong>- University degree and relevant industry experience or equivalent. Advanced degree is desirable (e.g., MSc, MPH, MBA, PhD)< li>
- Fluent proficiency in English language written and oral. Minimum of 10 years’ experience working in clinical research and development in the pharmaceutical industry (and or Contract Research Organizations) with specific experience in clinical documentation and or records & information management.< li>
- 3+ years’ experience in direct people management or matrix management of project clinical teams.< li>
- Deep understanding of drug development process, international drug approval procedures and standards (e.g. ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management (e.g. DIA TMF reference model).< li>
- Proven success in planning and executing cross functional change projects. Strong influencing and presentation skills. Ability to communicate effectively at all levels.< li>
- High organizational awareness in multi-disciplinary teams, across cultures and geographies.< li>
- Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders.
< li> < ul>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
Division
< strong>Global Drug Development
Business Unit
< strong>GDO GDD
Country
< strong>India
Work Location
< strong>Hyderabad, AP
Company Legal Entity
< u>< strong>Nov Hltcr Shared Services Ind
Functional Area
< strong>Research & Development
Job Type
< strong>Full Time
Employment Type
< strong>Regular
Shift Work
< strong>No
Early Talent
< strong>No < div>< body>< html>
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