Strategic Quality Lead

2 days ago


Dombivli, Maharashtra, India beBeeQuality Full time ₹ 1,75,00,000 - ₹ 2,25,00,000
Job Overview

As a Principal Central Monitor, you will play a strategic role in driving data integrity and operational excellence across clinical development programs through advanced centralized monitoring.

This position is responsible for developing and executing enterprise-wide strategies, leading risk assessments, and defining key performance indicators (KPIs) in collaboration with senior functional leaders.

Key responsibilities include:

  • Designing and implementing comprehensive quality management plans tailored to each study's needs
  • Conducting thorough risk assessments for clinical studies and developing mitigation strategies
  • Interpreting complex data patterns, leading root cause analyses, and driving decision-making to enhance study quality and compliance
  • Facilitating regular quality meetings to review and discuss study data, findings, and action plans
  • Ensuring the highest standards of data quality and integrity through proactive monitoring and timely interventions
  • Collaborating with clinical operations, data management, and other departments to support proactive oversight and management

Requirements:

  • Bachelor's Degree in a relevant field or equivalent combination of education, training, and experience
  • Minimum 8 years experience in clinical monitoring, clinical trial management or equivalent
  • Working knowledge of ICH GCP guidelines and the clinical development process

Preferred qualifications include CRO experience as a Central Monitor and proficiency in statistical analysis and quality management tools.

Qualifications Summary: This is a critical leadership position that requires strong clinical expertise, strategic thinking, and excellent communication skills.

What We Offer: A dynamic work environment, opportunities for professional growth, and a chance to make a meaningful impact on the success of our clinical development programs.



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