Job Overview
Provides operational support to the Clinical Research organization to ensure the wellbeing of clinical research subjects and the best possible project outcomes. Using a unified monitoring platform, leads data integration, predictive and advanced analytics, and site & patient management Executes and provides holistic and timely insights on patient, site, study, and program levels Uses data insights delivered by innovative technology, enhanced processes and new roles to optimize execution to support capabilities, and site support capabilities to improve efficiencies and enhanced patient focus to deliver optimal project execution.
Essential Functions
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 CML has particular focus on leading/advising the centralized monitors 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 and Skills
Bachelor of Science's degree in clinical, life sciences or related field
Requires minimum of 5 years of relevant 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.
Ability to work across cultures and geographies with a high awareness and understanding of cultural differences and maintain effective working relationships with coworkers, managers and clients.
To lead team and effectively work in team.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
