Clinical Validation Analyst I

Hi,

Are you passionate about improving the quality of human life? If so, we invite you to join us in creating a healthier world tomorrow.

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                                 : Clinical Validation Analyst II

Reporting to                          : Clinical Data Mgt Group Leader, Data Management

Type of Employment           : Full Time

Location                                 : Trivandrum (Office Based)

Summary:

•      To effectively manage the activities of individual studies in a manner that ensures all timeframes and targets are met and that costs are kept under control.

Experience Required

·         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.

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

·         Reviews Listing Validation  Specification document created by study team.

·         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.

·         Other responsibilities may be assigned as required

Academic or Trade qualifications:

•      Minimum educational degree requirements:  Bachelor’s degree in Life science

Benefit Working with ICON:

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, and life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. 

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.