Summary
-Responsible and accountable for managing all Data Mgmt/Coding / CDD/DAP aspects of several studies, a medium to large sized project or project level activities at a consistently high standard. The position is a key collaborator and strategic partner with stakeholders ensuring that pharmaceutical drug development plans in Novartis Global Drug Developnment are executed efficiently with timely and high quality deliverables. Conceptualize and implement, in a scalable way, appropriate training delivery models and platforms for end-to-end deliverables. Follows and oversees -Good Clinical Practices (GCP), data-handling procedures & guidelines. Ensure consistency across assigned program to aid efficiencies for submissionsParticipates in the review of clinical research protocols, reports and statistical analysis plans. Leads quality deliverables across platforms. Develops simple and reproducible strategies to ensure quality deliverables,
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About the Role
Major accountabilities:
• Accountable for Life Cycle Management of one or more business technology products
• Definition and execution of technology product road map in line with the end-2-end technology capability strategy of the business domain
• Preparing and managing technology product budget in accordance with Novartis Finance processes
• Oversight of performance of technology product and defines continuous improvement plans in collaboration with relevant IT teams
• Ensuring technology product is in compliance with GxP and Novartis CSV and Quality standards
• Hosting Voice of Business forum and SteerCo for technology product
• Accountable for audit & inspection readiness for technology products within Domain
• 2-4 years relevant clinical trial operations experience, from technology or health care sector. General understanding of drug development - early development, clinical trials, safety, data management, etc.
• Demonstrated success in defining and executing high-impact technology and innovation road maps. Experience from x-functional initiatives with focus on business benefit realization and fast business adoption
• Ability to influence without authority and successfully manage senior level stakeholders. Excellent oral/written communication skills - allowing effective interactions with all levels of the organization; able to present information confidently and effectively to leadership, peers and team
• Prior exposure design thinking methodologies is desirable. Strong collaboration skills are essential, including ability to work in multidisciplinary teams
• Good negotiation and conflict resolution skills. Strong interpersonal skills
• Well organized and results-focused - ability to meet difficult timelines in a dynamic environment.
Key performance indicators:
- Achieve high level of quality, timeliness, cost efficiency and customer satisfaction across Data Mgmt activities and deliverables.
- No critical audit findings due to Data Mgmt -Effectiveness of participation in internal and external networks/initiatives.
- Adherence to Novartis policy and guidelines -Customer / partner/ project feedback and satisfaction
Minimum Requirements:
Work Experience:
- Cross Cultural Experience.
- Functional Breadth.
- Project Management.
Skills:
- Clinical Data Management.
- Data Architecture.
- Data Governance.
- Data Integration.
- Data Management.
- Data Profiling.
- Data Quality.
- Data Science.
- Data Strategy.
- Master Data.
- Project Management.
Languages :
- English.
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Division
Development
Business Unit
Innovative Medicines
Location
India
Site
Hyderabad (Office)
Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No