Senior Clinical Data Specialist

2 days ago

Hyderabad, Telangana, India beBeeData Full time ₹ 30,00,000 - ₹ 50,00,000

Job Title: Senior Clinical Data Specialist

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We are seeking a skilled and detail-oriented Senior Clinical Data Specialist to join our team. In this role, you will be responsible for ensuring the accuracy and integrity of clinical trial data, as well as maintaining a controlled documentation system that meets regulatory requirements.

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Key responsibilities include:

  • Maintaining electronic records retention processes in accordance with regulatory agencies
  • Ensuring compliance to regulatory requirements
  • Maintaining technical and non-technical documentation change systems
  • Classifying and maintaining records
  • Interpreting and enforcing documentation formatting, standards, policies, and operating procedure requirements

Additionally, you may be involved in identifying submission components, communicating documentation standards, and coordinating assembly of regulatory dossiers. Your analytical skills will be essential in analyzing and evaluating data, extracting pertinent information, preparing information abstracts, and executive summaries of material searched.

As a Senior Clinical Data Specialist, you will work on problems of moderate scope, requiring analysis of situations or data involving a review of various factors. You will also be responsible for reporting technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.

To succeed in this role, you will need:

  • Cross-cultural experience
  • Functional breadth
  • Collaborating across boundaries
  • Operations management and execution
  • Project management

You will have strong skills in areas such as clinical study reports, data analysis, documentation management, lifesciences, operational excellence, and regulatory compliance. Proficiency in English is also required.

If you are a motivated and detail-oriented individual with excellent communication skills, we encourage you to apply for this exciting opportunity.

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