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Position Purpose:
We are looking for a passionate and Director Site Management and Monitoring (12 months contract) who is accountable for delivering the committed part of all clinical interventional studies under their supervision.
If you want to play a key role in the biggest CRO and in a Sponsor-dedicated role, this is your opportunity!
Job Overview
The Director Site Management & Monitoring is accountable for delivering the committed part of all clinical interventional studies under their supervision. according to agreed resources, budget and timelines complying with Sponsor's Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
He is responsible for line managing dedicated group(s) of staff and responsible for planning and utilization of staff resources, assigned budget, objective setting and performance follow-up.
It is also expected that he may contribute to regional/global work tasks as delegated.
As assigned, he is accountable for ensuring that study sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
Main Responsibilities:
Leadership of dedicated group of 10-12 direct reports of CRAs, CTAs and project managers , building the team spirit, developing team style and behaviour.
• Ensures adequate resources for the studies assigned.
• Ensures that the workload of direct reports is adequate.
• Development and performance management of direct reports.
• Ensures that direct reports have development and training plans.
• Coaches the direct reports on a regular basis, and plans/organises coaching with external providers if needed.
• Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible (Senior) Director, Country Head and local HRBP.
• Contributes to efficient SMM organisation and its functioning at country level by working closely with responsible (Senior) Director, Country Head.
• Contributes to high quality feasibility work.
• Oversees successful delivery of SMM study delivery country level targets to plan, with speed and quality.
• Contributes to the quality improvement of the study processes and other procedures.
• Ensures all systems are continuously updated.
• Ensures completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
• Assists (Senior) Director, Country Head or Local Study ADs/ Local Study Teams in forecasting study timelines, resources, recruitment, study materials and drugs.
• Provides direction to LSAD/ Local Study Teams on major study commitments including resolving any key issues identified.
• Supports SMM region in initiatives/activities as agreed with (Senior) Director, Country Head.
• Ensures collaboration with local Medical Affairs team.
• Ensures that study activities at country level comply with local policies and code of ethics.
• Reviews SQV reports of direct reports in line with Sponsor's SOPs
• Reviews Accompanied site visits/co- monitoring visits/training visits/QC visits performed to direct reports in line with the local QC plans.
• Performs accompanied site visits according to local QC Plan, supporting ongoing coaching and development.
Our ideal candidate: Skills & other requirements:
• Bachelor degree in related discipline, preferably in life science, or equivalent qualification (*).
• Minimum 5 years of experience in Development Operations (CRA / SrCRA / LSAD) or other related fields.
• Proven project management experience.
• Line management experience is needed
• Good knowledge of study start up is needed
• Excellent knowledge of spoken and written Turkish and English.
We invite you to join IQVIA™, an equal opportunity employer!
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IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.
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