Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Clinical Data Standards Lead
Job Description
Builds, manages and leads development of standards within platform, franchise or therapeutic area. Drives participation and input cross functionally in the standardization of content which satisfies requirements and aligns with reporting needs for safety and efficacy in Global Drug Development (GDD). Develops simple and reproducible standards of high quality (in design and function), and enables organization to be agile and deliver timely review and approval of standards to drug development programs. Progresses Novartis towards complete, agile and simple end to end standards (Protocol/Measure through Analysis and Reporting).
1. Plan, lead and implement Clinical Data Standards (CDS) within platform, franchise or therapeutic area. Leads cross functional discussions within GDD in support of standards development. Leads Data Management and CDS towards agreed deliverables, proactively addressing potential issues before they become problematic
2. Actively participate in CDS Team and partners with organization to progress data management towards industry best practices, simplification and deliverable effectiveness.
3. Manages and measures standards effectiveness (quality, timeliness, cost, customer service) withn platform, franchise or therapeutic area. Appropriatley manages budget within remit to ensure deliverables are met effectively and to plan.
4. Build and maintain strong partnerships within GDD with special focus within Data Management, Statistical Programming, Safety, Statistics, Quality and Clinical functions.
5. Lead independently or participate in improvement initiatives and/or non-clinical projects
6. Helps develop and complies with relevant SOPs/Working practices/trainings. Proactively reviews existing processes and identify opportunities for improvement
7. Lead/participate and keep current in Industry data standards activities. Ensure Novartis participation in industry organizations including Clinical Data Interchange Standards Consortium/The Coalition for Accelerating Standards and Therapies/ Clinical Data Acquisition Standards Harmonization (CDISC/CFAST/CDASH) as part of the Leadership team providing one voice for Novartis.
Candidate Profile :
Bachelor’s degree in Life Sciences, Computer Science, Medical Informatics or equivalent. Preferred Post-graduate university or college degree in Life Sciences, Computer Science, Medical Informatics Fluent English (oral and written).
1. Significant relevant experience and knowledge in the Pharmaceutical or Device Industry including experience in CDISC standardization, ICH and other Health Authority guidelines.
2. At least 7 years of experience in global drug development, within the pharmaceutical or device industry
3. A demonstrated leader and expert in Data Standards
4. Strong leadership skills including leading without direct authority, operations, and innovation globally in complex matrix structures and business models.
5. Superior interpersonal and communication skills. Builds positive departmental and inter-departmental relationships.
6. Proven ability to proactively identify issues, recommend and implement solutions
Additional Information:
Experience: 7 years
Qualification: Degree in Life Science
Industry Type: Pharma/ Healthcare/ Clinical research
Location: Hyderabad
Functional Area: Research & Development
Job ID: 215387BR
Last Date: 5th July, 2017
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