Sr Clinical Validation Analyst

Hi,

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.

We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.

Job Title                               : Senior Clinical Validation Analyst

Type of Employment           : Full Time

Location                               : ICON PLC, INDIA - Chennai

Responsibilities:

·         Experience in test script writing and testing for EDC systems.

·         Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.

·         As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

·         Travel (approximately 0%) domestic and/or international.

·         Performs validation/testing activities according to relevant ICON/Sponsor SOP's and appropriate regulations.

·         Reviews Data Validation Specification (DVS) document created by study team.

·         Tests the clinical study database, as per procedure.

·         Writes and executes formal test scripts and reports test results accurately in a timely manner.

·         Reviews Listing Validation Specification document created by study team.

·         Creates and executes test data and validates listing outputs as per the study/sponsor requirements.

·         Maintains and completes study documentation in a timely manner following ICON or Sponsor procedures, as applicable.

·         Communicates with test lead and/or team regarding system testing progress and issues.

·         Works closely with other supporting departments to ensure all testing issues are resolved in a timely manner and study timelines are met.

·         Completes assigned tasks within budget and timeline constraints and reports any quality issues to lead or manager in a timely manner.

·         Attends sponsor audits and assists with in-progress audits, as needed.

·         Participates in and contributes to internal user group meetings to share knowledge and provides latest update/features. Participates in Data Management department initiatives.

·         Contributes to training materials on a process, system or technology level. Works with ICON University and CDMS management on delivery of training courses, instructor-led and on-the-job.

·         In the role of mentor, assist and guide new personnel during their initial training period. • Manages validation activities for one or more projects, ensuring that timelines are met and deliverables are of sufficient quality.

·         Reviews test scripts and other testing deliverables.

·         Other responsibilities may be assigned as required

Benefits of Working in ICON

In comparison with our competitor’s and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comer’s to be highly respected professionals in our industry. ICON also provides successful candidates with an excellent employment package and benefits adapted to the current job market.

We are more like an extended family with consideration of staff as individuals allowing a work-life balance.

You would be joining us at the very right time – just when we won the Best Contract Research Organisation Award at the annual Scrip Awards 2017. 

If you would like more information please visit our company website: http://www.iconplc.com/ or careers.iconplc.com.

PROCESS

Technical and competency selection:

When you spot an opportunity you’re interested in and submit an application, one of our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business.

The evaluation will look at your technical skills and your competencies – for example, delivering excellence.

Interview

After this, we’ll let you know if we’ll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.

Offer

If you’re successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have – and above all, welcome you to the ICON team.