Site Management Lead

IQVIA Argentina; Wien; Vor Ort; EUR 75.000 - 110.000; Vollzeit

Zusammenfassung

IQVIA Clinical Functional Service Partnerships is seeking a Site Management Lead to supervise site monitoring activities across trials, ensuring patient safety and data reliability. You will lead planning, oversight, and issue resolution, and provide training to CT managers and CRAs, contributing to trial success and regulatory readiness.

The role requires a university degree in life sciences or equivalent, at least five years of clinical operations experience, and fluent English.

Qualifikationen

• University degree in life sciences or related field or equivalent professional education.
• At least five years of relevant clinical operations experience.
• Fluent in English.
• Strong leadership and influencing skills.
• Deep knowledge of ICH-GCP, regulatory requirements, and risk-based monitoring.

Aufgaben

• Lead planning of trial quality and risk monitoring/mitigation.
• Develop and implement Site Monitoring & Oversight plans.
• Deliver training and guidance to CT Managers and CRAs.
• Independently author and review trial-level documents.
• Act as SME on site management and monitoring topics.
• Represent monitoring strategy in global/regional/local meetings.
• Oversee CRO performance and adherence to ICH-GCP and SOPs.
• Drive issue management and mitigation at trial level.
• Coordinate timely data delivery and trial close-out activities.

Kenntnisse

Leadership

ICH-GCP

Regulatory knowledge

Trial management

English fluency

Ausbildung

University degree in life sciences or related field

Tools

Lead CRA background

Clinical Trial Management

Jobbeschreibung

IQVIA Clinical Functional Service Partnerships (Clinical FSP) department is providing highly skilled professionals to our client’s project team to set-up and execute clinical trials.

Site Management Lead

The Site Management Lead 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 role contributes to the overall success and delivery of their assigned clinical trials according to defined milestones and key performance indicators.

The SML is responsible 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, compliance with study protocol, sponsor obligations, ICH‑GCP and applicable regulations and manages inspection readiness at all times.

Main Responsibilities

Trial Preparation

• Lead planning of trial quality and risk monitoring/mitigation.
• Accountable for development and implementation of operational Site Monitoring & Oversight plans.
• Deliver training and guidance to CT Managers and CRAs.
• Independently author and review trial-level documents.
• Act as subject matter expert on site management and monitoring topics.
• Join and presents at global/regional/local Trial Team meetings and Investigator Meetings.
• Integrate patient/site level feedback to the documents ensuring design with a focus on the patient and patient safety.
• Represent monitoring strategy in global/regional/local meetings.
• Timely responses to Site Management and monitoring questions from external and internal stakeholders (including Regulatory Authority/Ethics Committee).
• Facilitate communication and direction with Clinical Trial Leaders, Clinical Operations Coordinators, CT Managers and CRAs.

Trial Conduct

• Independently oversee CRO performance and adherence to ICH‑GCP and SOPs.
• Drive issue management and resolution at trial level.
• Proactively identify trial and site level risks and implement mitigation strategies.
• Maintain and update Site Monitoring plan and trial-level documents to ensure and maintain Risk-based Site Monitoring approach for the trial
• Conduct oversight visits and ensure follow-up actions.
• Lead preparation and implementation of trial document amendments and retraining.
• Provide strategic communication and training.
• Communication with Clinical Trial Leaders, Clinical Operations Coordinators, CT Managers and CRAs, perform re-training etc.
• Participate, prepare input and (co-) lead Trial Oversight Meetings (country and trial level) and contribute to the timely responses to questions from external and internal stakeholders (including Regulatory Authority/ Ethics Committee).

Trial Close‑out

• 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.

Qualifications and Requirements

• University degree in life sciences or related field OR equivalent professional education with extensive experience in clinical operations and site monitoring required.
• At least five years of relevant clinical operations experience.
• Fluent in English.
• Strong leadership and influencing skills.
• Deep knowledge of ICH‑GCP, regulatory requirements, and risk-based monitoring.
• Profound CRA background with Lead level CRA responsibilities, combined with initial exposure to selected tasks in Clinical Trial Management.
• Initial experience in portions of Clinical Trial Management.
• Proven ability to manage complex trials across regions and vendors.
• Demonstrates AAI approach in leading and decision‑making.

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.