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Novartis
Novartis
H1B वीज़ा प्रायोजकपरामर्शविनिर्माणस्वास्थ्य सेवा
Novartis एक वैश्विक स्वास्थ्य सेवा कंपनी है, जो ऐसी नवीन दवाओं की खोज और विकास पर केंद्रित है जो लोगों के जीवन को बेहतर बनाने और उसे लंबा करने में मदद करती हैं। इसका अनुसंधान और विकास कार्य हृदय एवं रक्तवाहिका संबंधी, गुर्दे और चयापचय संबंधी रोगों, प्रतिरक्षा विज्ञान, तंत्रिका विज्ञान और कैंसर विज्ञान जैसे क्षेत्रों में फैला हुआ है। कंपनी वैज्ञानिक सहयोग और आधुनिक प्रौद्योगिकी प्लेटफ़ॉर्म के साथ-साथ विविधता, समानता और समावेशन तथा सामाजिक और पर्यावरणीय उत्तरदायित्व पर भी ज़ोर देती है, ताकि चिकित्सा क्षेत्र को आगे बढ़ाया जा सके।
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कंपनी की नौकरियाँ

Senior Clinical Data Scientist at Novartis

Lead clinical data management, quality, and regulatory deliverables for Novartis trials. Coordinate study teams, data reviews, testing, and process improvements from the Hyderabad or Mumbai offices.

INभारतऑन-साइटपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीडेटा वैज्ञानिक

विवरण

  • Deliver Data Management products and milestones efficiently for assigned clinical trials.
  • Lead Data Management across assigned trials and serve as Trial Data Manager when needed.
  • Apply knowledge of compound profiles to support Data Management processes.
  • Review protocols and amendments and provide feedback.
  • Resolve protocol issues that affect database design, data validation, analysis, or reporting.
  • Complete study start-up Data Management work, including Data Handling Plans, Data Review Plans, and user acceptance testing.
  • Set up local laboratories for clinical databases where applicable.
  • Lead process and training deliverables for platforms or processes.
  • Meet global regulatory requirements and business objectives.
  • Coordinate data operations for audits and inspections.
  • Manage quality issues, exception requests, deviations, and corrective and preventive action plans.
  • Carry out hands-on Data Management work throughout each study.
  • Review clinical study data, including third-party and local laboratory data and SAE reconciliation where applicable.
  • Align assigned trials with program-level Data Management standards and documentation.
  • Prepare data-review listings for study teams as needed.
  • Prepare study status reports for clinical trial team meetings.
  • Support junior staff on assigned trials.
  • Contribute to Data Management initiatives focused on innovation, quality, efficiency, continuous improvement, scientific excellence, and operational excellence.
  • Lead or coordinate synonym reviews and dictionary version upgrades at trial or program level.
  • Serve as primary study lead, building strong relationships with study teams and functional lines to deliver work on time and to quality standards.
  • Provide technical consulting as required.

आवश्यकताएँ

  • Work effectively under pressure and demonstrate agility through effective, innovative team leadership.
  • Bring excellent interpersonal skills and the ability to operate effectively in a global environment.
  • Influence and communicate across functions and with external stakeholders.
  • Demonstrate the ability to interrogate and view data using programming or GUI techniques.
  • Have excellent problem-solving skills.
  • Ideally have four years of Drug Development experience, including at least three years in Clinical Data Management.
  • Have excellent verbal and written communication skills.
  • Know Clinical Data Management, Data Governance, Data Integrity, Data Management, Data Quality, Data Science, and the Waterfall Model.

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