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DMC

Competitive Compensation Package

This is an exciting opportunity to work within 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

Excellent critical thinking skills
Data Management experience is a plus
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%.

Benefits

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

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.

What’s Next

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.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment

Impactful work. Meaningful careers. Quality rewards.

At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential.
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