Talent Pal
Location
Chennai | India
Job description
At ICON its our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients lives.
Our Own It culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery Collaboration Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touchpoint. In short to be the partner of choice in drug development.
Thats our vision. Were driven by it. And we need talented people who share it.
If youre as driven as we are join us. Youll be working in a dynamic and supportive environment with some of the brightest and the friendliest people in the sector and youll be helping shape an industry.
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 followup of dossiers provided to Clinical Events Committees for marketed products and investigational compounds being studied in Endpoint Driven trials.
Roles & responsibilities:
Registered Nurse is required along with two or more years of relevant work experience in drug development or clinical industry.
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%.
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 unblinding extract Endpoint/AE data from various source documents and spontaneous sources.
Manages caserelated 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.
Benefits of Working in ICON:
Our success depends on the quality of our people. Thats why weve made it a priority to build a culture that rewards high performance and nurtures talent.
We offer very competitive salary packages. And to keep them competitive we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals both ours and yours.
We also provide a range of healthrelated benefits to employees and their families and offer competitive retirement plans and related benefits such as life assurance so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits youll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.
ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or protected veteran status.
If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or in order to perform the essential functions of a position please let us know
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