Location –Warrington, PA
This is an exciting opportunity toworkwithin a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.This individual will manage activities relating to the collection, processing, analysis and follow-up of dossiers provided to Clinical Events Committees for marketed products and investigational compounds being studied in Endpoint Driven trials.
Overview of the Role
Ensures timely collection of documents and components of Adjudication Packages for Clinical Endpoint Committees to allow quality and complete adjudication of potential clinical endpoints occurring in clinical trials. Collect, QC and ensure that the package content is medically complete and appropriate to allow physician adjudicators the ability to apply objective endpoint definitions to each case presented to them.
Must have knowledge of and adherence to all applicable aspects of Good Clinical Practices, Federal Regulations, International standards and company SOPs is required.
Will construct medically complete and logical adjudication dossiers for presentation to physician adjudicators. Also responses to queries from Physician adjudicators, Clinical Site Personnel, Company Personnel as it relates to collection of dossier components.
Will be responsible for, in collaboration with project management, generating status and progress reports for committees and tracking performance and quality among adjudicators. They will also work with Project Management and Clinical Operations to generate all necessary committee documentation, preparing periodic reports and reviews of certain cases, identify potential sources of un-blinding, extract Endpoint/AE data from various source documents and spontaneous sources.
Manages case-related information including interpretation of medical conditions, lab results, and procedures as well as compile complete narrative summaries and ensure proper coding (MedDRA) into the Clinical Endpoint Committee database.
Role Requirements / Skills / Experience Required
Bachelor's degree in a scientific or medical discipline and two or more years of relevant work experience in drug development, clinical monitoring or drug safety is required.
Experience working with FDA regulations and reporting requirements and experience working with the MedDRA dictionary is preferred.
Experience working with electronic data (eCRFs), Microsoft Office Applications and other electronic data capture and transfer methods is highly desirable.
Excellent verbal and written communication skills. Must be detailed oriented and possess excellent organizational skills.
Willingness to travel 10%.
Working for ICON Medical Imaging you will be provided with an excellent benefits package.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
In addition you will have the opportunity to develop within your role and take on further responsibilities or develop your skill set within other related departments of ICON Medical Imaging.
Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.
Clinical - Operations
09/Apr/13, 1:45:53 AM
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