Job Description

Clinical Nurse Reviewer I- Bengaluru/ Chennai/ Trivandrum- Home basedICON plc is a world-leading healthcare intelligence and clinical research organization. Wexe2x80x99re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentAt ICON, itxe2x80x99s 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 patientsxe2x80x99 lives.Our xe2x80x98Own Itxe2x80x99 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 touch-point. In short, to be the partner of choice in drug development.Thatxe2x80x99s our vision. Wexe2x80x99re driven by it. And we need talented people who share it.
If youxe2x80x99re as driven as we are, join us. Youxe2x80x99ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and youxe2x80x99ll 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 follow-up 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 skillsShould have clinical research experienceData Management experience is a plusExperience 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.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.Benefits of Working in ICON:
Our success depends on the quality of our people. Thatxe2x80x99s why wexe2x80x99ve 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 xe2x80x93 both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans xe2x80x93 and related benefits such as life assurance xe2x80x93 so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, youxe2x80x99ll 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 through the form below.#LI-MR1What ICON can offer you:Our success depends on the quality of our people. Thatxe2x80x99s why wexe2x80x99ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:Various annual leave entitlementsA range of health insurance offerings to suit you and your familyxe2x80x99s needs.Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familyxe2x80x99s well-being.Life assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.Visit our to read more about the benefits ICON offers.At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work wexe2x80x99ve done to become a more inclusive organisation. Wexe2x80x99re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request .Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless xe2x80x93 therexe2x80x99s every chance youxe2x80x99re exactly what wexe2x80x99re looking for here at ICON whether it is for this or other roles.Are you a current ICON Employee? Please click to apply

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