Investigational Medicinal Product (IMP) Specialist

<h2>Job Overview:</h2><p style="margin: 0px;">As a leading contract research organization (CRO), Labcorp Drug Development (formerly known as Covance) provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.</p><p style="margin: 0px;"> </p><p style="margin: 0px;">Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.</p><p style="margin: 0px;"> </p><p style="margin: 0px;">Role Details:</p><p style="margin: 0px;"> </p><p style="margin: 0px;">We are recruiting for our FSPx business in Turkey and are currently seeking to hire a sponsor-dedicated IMP Specialist (Investigational Medicinal Product Specialist) with a permanent and full-time contract. In this role, you will have a home-based contract. This is a great opportunity for experienced Clinical Research Associates who do not prefer to travel anymore.</p><p style="margin: 0px;"> </p><p style="margin: 0px;">The Investigational Medicinal Product Specialist (IMPS) will assist with the management of the Investigational Medicinal Products (IMP) and non-IMP inventory from receipt through destruction. This responsibility is performed within the CSU and works with study Monitoring Teams, distribution warehouse/depot and/or other third-party groups.</p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Effective IMP management requires interacting with a number of groups, including local sites, external service providers and regional internal colleagues; therefore proactive communication is required to ensure adequate planning.</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;">Responsibilities include but are not limited to:</p><ul><li>Ensures the day-to-day processing of IP inventory is as per local SOPs and procedures</li><li>Coordinates and collates the receipt, storage, inventory, shipment, acknowledgment of receipt, return, reconciliation and destruction of IMP/non-IMP with the Warehouse, Study Monitoring Teams, CTOMs and external partners</li><li>Ensures the local study files are complete as per local SOPs and are audit ready</li><li>Monitor IP tracking tables (IPTT) or CSMS (Clinical Supply Management System) to ensure ongoing completion by monitoring teams for site shipment and receipt, return and destruction</li><li><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Tracks temperature excursions and provides data entry support as needed for both IPTT & CSMS</span></li></ul><h2>Education/Qualifications:</h2><p style="margin: 0px;"> </p><ul><li>University graduate with a degree in life sciences (Pharmacy degree preferred but not a must)</li><li>Knowledge of the life cycle management of Investigational Medicinal Products (IMP) and non-IMP from receipt to destruction preferred</li><li><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Experience with IVRS, IMP and non-IMP inventory tracking including usage, returns, reconciliation and destruction is desirable</span></li><li><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Basic knowledge of Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), CFR, ICH regulations pertaining to IP is needed</span></li><li><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">Computer experience with Microsoft Office (especially Excel), IMPACT (or any clinical trial management system) and Interactive Voice Response System (IVRS) will be considered a plus</span></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 11.0pt; font-family: 'Calibri',sans-serif;">3+ years of experience in clinical operations within the pharmaceutical industry with minimum 2 years of clinical monitoring background</span></li></ul>