Site Monitoring Lead

IQVIA•Durham, NC

1d•$68,400 - $171,000

About The Position

Site Monitoring Leads are accountable for authoring the monitoring risk assessments and plans, maintaining sponsor oversight, trend analysis, signal detection and delivery of their assigned trials in close collaboration with the IQVIA partner to provide delivery of the Sponsor’s pipeline through accurate planning and efficient execution of Site Monitoring in trials that bring speed & value to participating subjects and sites. Provides Site Monitoring expertise to and consults the Trial Team, leads and oversees the implementation of the Site Monitoring & Oversight approach and activities as part of overall clinical trial quality management. The Site Monitoring Lead is accountable for managing the trial level planning, implementation, issue management, and oversight of the Site Monitoring activities of a trial as assigned, to safeguard the protection of the trial subject, reliability of the trial results, and compliance with study protocol.

Requirements

Bachelor's level degree in life sciences OR several years of equivalent professional education.
Solid knowledge in and experience with Site Monitoring and Site Management processes and accountabilities.
Fluent in English (written and spoken).
Demonstrates Accountability Agility Intrapreneurship (AAI) approach and skills in complex cross-functional matrix structures of the trial and extended team. Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action.
Demonstrates active listening skills and cultural awareness.
Demonstrates scientific and therapeutic knowledge and operational expertise across all Site Monitoring aspects in clinical trial planning and execution. Dimensions of trial complexity include protocol, patients, sites, countries, vendors.
Demonstrates skills and capabilities in addressing complex situations, confidently coordinating and overseeing teams.

Responsibilities

Plan trial quality and risk monitoring/ mitigation as part of the Trial Team.
Deliver Risk-based Site Monitoring approach and training for the trial.
Accountable for the development of the operational Site Monitoring & Oversight plans.
Develop and provide appropriate training of Site Monitoring to Clinical Trial Managers (CT Manager) and Clinical Research Associates.
Act as an expert and consultant on Site management and monitoring topics.
Integrate patient/site level feedback to the documents ensuring design with a focus on the patient.
Provide timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/ Ethics Committee).
Facilitate communication and direction with CT Managers and IQVIA CRAs.
Monitor progress and oversee Site Management and Monitoring activities conducted by IQVIA partners during clinical trial conduct including adherence to ICH-GCP and regulatory requirements, compliance with SOPs, trial protocol, trial quality management and Site Monitoring plans.
Pre-identification of important protocol deviations from site deviations.
Continuous review, risk identification, evaluation and communication on a trial level.
Maintain Risk-based Site Monitoring approach for the trial and update Site Monitoring plan and trial level documents.
Conduct Site and Monitoring Oversight (including Site Monitoring Oversight Visits).
Facilitate communication and training related to site monitoring in the trial.
Coordinate timely cleaning and delivery of clinical trial data with Trial Team and countries.
Support compilation and review of the quality section for the clinical trial report for site monitoring activities.