Overview

• Provides leadership of the centralized monitoring team, in partnership with project and clinical lead, and in collaboration with other functional teams, to achieve the delivery of the project’s overall objectives to the sponsor’s satisfaction per contract while optimizing speed, quality and cost of delivery and in accordance with our standard operating procedures, policies and practices.
• The Centralized Monitoring Lead has particular focus on leading/advising the centralized team (centralized monitors and centralized monitoring assistants) towards solutions to clinical risks identified and facilitating successful implementation of those strategies to address the issues.
• Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards.
• Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with IQVIA standard operating procedures,  International Conference on Harmonization - Good Clinical Practice (ICH GCP)  guidelines, protocol requirements and regulatory compliance. 
• Provide expertise support in the Centralized monitoring studies from Applications, Analytics and Therapeutics or Quality perspective.

Qualifications, Experience and Skills Required

• Bachelor's Degree in clinical or life sciences, or related field, or medical degree. 
• Requires minimum of 5 years of relevant experience or Medical degree with a minimum 4 years of clinical trial experience.
• Advanced knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e., International Conference on Harmonization - Good Clinical Practice (ICH GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
• Good Clinical system expertise.
• Strong written and verbal communication skills including good command of English language.
• Results and detail-oriented approach to work delivery and output.
• Understanding of clinical/medical data.
• Good motivational, influencing, negotiating and coaching skills.
• Ability to work on multiple projects and manage competing priorities.
• In depth therapeutic and protocol knowledge.
• Strong organizational, problem solving and decision-making skills.
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
• Effective presentation skills.