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Senior Principal Clinical Data Manager

Hyderabad, India
Closing date
Nov 29, 2022

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Physical Sciences, Information Technology
Position Type
Full Time
Job Type
Organization Type
All Industry, Pharma
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Job Description

50 Plus global studies will be the magnitude of the function to which you will be partnering as a team member. Within the Biometrics function you will be playing a key role in taking the accountability and delivering studies end to end of Data Management solutions. Will get opportunity to work on varied clinical studies of all phases which includes Interventional, Non- Interventional, Chart review, Observational, Prospective & Retrospective studies across all therapeutic areas.
At Novartis NBS CONEXTS we aim to provide innovative solutions to help Novartis medical and scientific teams re-imagine medicine, Delivering cost effective and scalable competitive solutions through focus on productivity, Building assets and competitive Novartis solutions, enhancing innovation and our unique service offering, Providing leading edge quality and innovation through our expert global workforce.
Job Purpose
Responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to project management, cost, quality and timelines for all clinical indications across franchises within Biometrics and partner with customers.
Major Activities
• Provides DM leadership & supervision in the capacity of Subject Matter Experts (SMEs), and also Supervises long term training activities ensuring the development of DM SMEs. Demonstrates a business understanding of the compound profile / Therapeutic Area (TA) to identify and assist in successful application of data management processes.
• Develops and contributes towards SOPs & Data Management standards (e.g. Protocols, DHPs/DRPs & eCRF/CCGs) and assure adherence across trials. Should be able to lead and provide expert opinion/input into DM initiatives and innovations for quality, efficiency and continuous improvement in scientific and operational excellence
• Strong working understanding and its impact on Database design principles, technology platforms and understanding of the CDISC or other recognized standards.
• Develop metrics, KPIs & KQIs to monitor and ensure robustness of DM deliverables. Supervises CDM presentations for Investigator Meetings, CRA workshops, and Project Kick-off meetings including Data Management documents, as appropriate.
• For studies which have central data monitoring, CDME (central data monitoring expert) will supervise/monitor for all oversight of the data including DM deliverables.
• Develops risk management strategies to proactively prevent data quality issues by consistently and efficiently monitoring of data trends, that would be signals of potential fraud/misconduct, previously unrecognized quality concerns, or a sign of slippage in some aspect of study management
• Ensure timely completion of data management archiving; as necessary; respond to Health Authority/FDA/audit requests pertaining to project-specific data management issues.
• Supervises individual contributors and may depute for Team Leader (TL), also appropriately plans with the TL to ensure adherence to timelines, identifies and proposes solutions to address resources, budget & timelines issues by setting priorities within the group. Participate in clinical & non-clinical special projects. May assist in hiring, coaching, training, career planning, performance appraisals and mentoring of other Data Management staff.

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

• Ideally 8 or more years’ experience in drug development, with at least 7 years in Data Management activities. Experience in managing outsourced studies or working for a CRO.
• Good Knowledge in managing & preparing study budgets.
• Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding.
• Project team leadership experience; good organizational and project management skills. Good technical and problem solving skills.
• Ability to work independently, under pressure, demonstrating initiative and flexibility.
• Attention to detail and quality focused.
• Good interpersonal and communication skills and ability to operate effectively in an international environment. Good negotiation skills.
• Ability to mentor, coach within Data Management and cross functionally, and train internal and external partners.

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.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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:
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