[FRESHERS] NOVARTIS HIRING CLINICAL DATA SPECIALIST

Job Title: Clinical Data Specialist
Company: Novartis
Job ID: 393921BR
Date Posted: May 07, 2024
Location: India

Summary:
Novartis is seeking a Clinical Data Specialist to contribute to global clinical trials, ensuring they meet schedule, budget, quality, compliance, and performance standards. The role involves leading specific trial aspects and promoting operational excellence through process improvement.

Major Accountabilities:

1. Operational/Clinical Trial Deliverables:

• Adhere to timelines, budget, operational procedures, and quality standards.
• Ensure compliance with performance standards and regulatory requirements.

1. Study Start-up Activities:

• Oversee protocol, CRF, and Informed Consent Form development.
• Contribute to study feasibility and planning.

1. Site Identification and Analysis:

• Identify new sites for clinical trials.
• Analyze site capabilities and make recommendations for trial inclusion.

1. Study Conduct and Close-out Activities:

• Manage study conduct activities ensuring compliance.
• Oversee site close-out, final drug accountability, and Trial Master File documentation.

1. Compliance and Education:

• Implement and ensure compliance with SOPs and best practices.
• Share lessons learned and promote knowledge sharing.

1. Technical Complaints & Adverse Events:

• Report technical complaints, adverse events, and special case scenarios related to Novartis products promptly.
• Distribute marketing samples as required.

Key Performance Indicators:

• Timely, efficient, and quality execution of assigned trials within budget.
• Proactive operational planning with effective risk mitigation.
• Adherence to Novartis policies, guidelines, and external regulations.

Skills Required:

• Trial Planning and Feasibility.
• Over The Counter Product Development.
• Post Authorization Data Safety.
• Regulatory Strategy.
• Clinical Trial Set-up, Management & Conduct.

Languages: English

How to Apply: Interested candidates can apply by submitting their resume through the Novartis careers portal or via email to hr@novartis.com.

Meta Description: Novartis is hiring a Clinical Data Specialist in India to contribute to global clinical trials’ success. Join us for an exciting opportunity in clinical research and compliance. Apply now!