Principal Clinical Data Scientist
Location
Secunderabad | India
Job description
About The Role
Principal Clinical Data Scientist
Location – Hyderabad/Mumbai
About the Role:
The principal data Scientist is responsible and accountable for managing all Data Management deliverables at a consistently high standard with respect to cost, quality and timelines for all assigned indications within one or more Global Clinical Program(s). Coaches TDMs to provide leadership to project/study teams Ensure consistency across assigned program to aid efficiencies for submissions Provide active and effective communication to Global Program teams and other stakeholder groups.
Key Responsibilities:
- 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 qand 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 standardsCommunicates 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.
Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Role Requirements Essential Requirements :
- University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.Fluent English (oral and written).
- 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
Desirable Requirement:
- 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.
- Ideally 8 years' experience in Drug Development with at least 5+ years' in Clinical Data Management
- Understanding of project management concepts in order to aid delivery across a program
- Excellent verbal and written skills
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Commitment to Diversity and 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:
Division Development
Business Unit GCO GDD
Work Location Hyderabad, AP
Company/Legal Entity Nov Hltcr Shared Services Ind
Functional Area Research & Development
Job Type Full Time
Employment Type Regular
Shift Work No
Early Talent No
Job tags
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