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Clinical Scientific Expert - I

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Novartis

10d ago

  • Job
    Full-time
    Entry, Junior & Mid Level
  • Research & Development
    Healthcare
  • Hyderabad, +1

AI generated summary

  • You need experience in clinical research, project management, and cross-cultural collaboration, along with skills in data integrity, risk monitoring, and trend analysis. Proficiency in English is required.
  • You will implement issue resolution plans, manage program activities, ensure timely reporting, execute trials efficiently, conduct data reviews, and contribute to study documents while upholding Novartis values.

Requirements

  • Work Experience:
  • Cross Cultural Experience.
  • Operations Management and Execution.
  • Collaborating across boundaries.
  • Project Management.
  • Skills:
  • Clinical Research.
  • Clinical Trial Protocol.
  • Clinical Trials.
  • Data Integrity.
  • Learning Design.
  • Lifesciences.
  • Risk Monitoring.
  • Trends Analysis.
  • Languages :
  • English.

Responsibilities

  • Implementing issue resolution plans;
  • Assist with program level activities (e.g., tracking of program
  • Managing interactions with relevant line functions including data management, drug supply management, clinical development and/or Novartis Country Pharma Organizations;
  • Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt
  • Distribution of marketing samples (where applicable)
  • Timely, efficient and quality execution of assigned trials and trial related activities within budget, and in compliance with quality standards.
  • Proactive operational planning with effective contingency and risk mitigation plans.
  • Performing clinical data review and insights consistently and accurately which meets the Novartis quality standards, timelines, and is inspection ready.
  • High quality contributions to study documents (e.g. protocol, ICF, clinical sections of CTA)
  • Clearly demonstrates Novartis Values and Behaviors (i.e. Innovation, Quality, Collaboration, Performance, Courage and Integrity.

FAQs

What is the role of a Clinical Scientific Expert - I at Novartis?

The Clinical Scientific Expert - I (CSE I) provides clinical and scientific support throughout all phases of a clinical study, ensuring compliance with Novartis processes, ICH GCP, and regulatory requirements while contributing to the global clinical trial activities.

What are the key responsibilities of this position?

Key responsibilities include implementing issue resolution plans, managing interactions with relevant line functions, supporting program-level activities, reviewing clinical data, and contributing to study documents such as protocols and informed consent forms.

What qualifications are required for the Clinical Scientific Expert - I role?

The minimum requirements include cross-cultural experience, operations management and execution, collaboration across boundaries, and project management skills. Proficiency in clinical research, clinical trial protocols, data integrity, and trend analysis is also essential.

What skills are essential for success in this role?

Essential skills include clinical research, understanding clinical trial protocols, data integrity, risk monitoring, and trends analysis, along with a background in life sciences.

Is knowledge of regulatory requirements important for this position?

Yes, knowledge of regulatory requirements, including ICH GCP, is crucial for ensuring compliance during clinical trials.

What are the performance indicators for the Clinical Scientific Expert - I role?

Key performance indicators include timely and efficient execution of trials within budget and compliance standards, proactive operational planning, quality contributions to study documents, and adherence to Novartis values and behaviors.

In which location is this position based?

The Clinical Scientific Expert - I position is based in Hyderabad, India.

What is the work environment like at Novartis?

Novartis fosters a collaborative and inclusive work environment, emphasizing teamwork, support, and innovation among employees to achieve breakthroughs that impact patients' lives.

Does Novartis offer opportunities for career growth?

Yes, Novartis provides opportunities for personal and professional development, and encourages employees to join their talent community to learn about suitable career opportunities.

Does Novartis provide accommodations for individuals with disabilities?

Yes, Novartis is committed to providing reasonable accommodations for individuals with disabilities during the recruitment process and in performing essential job functions.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world.

Culture & Values

  • Inspired

    Engage our people. Strive for patients. Live our purpose

  • Curious

    Learn. Be open. Be self-aware

  • Unbossed

    Create clarity. Serve others. Own your actions

  • Integrity

    Be honest. Have courage. Do what’s right