CDC II

“At ICON, it's our People that set us Apart”

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.

Position Summary

Serve as a resource tor projects, deliverables. and improvement initiatives in the Data Management department.

Perform data management activities to ensure the generation of accurate, complete, and consistent clinical data, and support timely project delivery to the highest quality.

Ensure all activities are conducted in accordance with Good Clinical Practices (GCP), applicable SOPs, client requirements, and departmental requirements.

Job Responsibility

·         *Recognize, exemplify and adhere to ICON's valL}es which centers around our commitment to People. Ciients 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

·         *Perform Quatity Reviews and appropriately address all issues.

·         *Compile and distribute necessary study documentation and maintain accurate and complete study flies jn accordance with atl applicable procedures.

·         'Identify and appropriately address data discrepancies (n the clinical data via computerized edits and manuat checks/listings.

·         *Independently and accurately generate data queries to resolve data discrepancies.

·         *Appropriately address responses to data queries and accurately update the clinical data as necessaty.

·         *Accurately and consistently apply data handling conventions to Case Report Forms as necessary in accordance with all applicable procedures.

·         *Independently and accurately prepare database test documentation and test data entry screens.

·         *Assist with the validation of edit check programs.

·         *Assist with the development, review, and maintenance of relevant Data Management Study Specific Procedures.

·         *Accurately perform Serious Adverse Event reconciliation in accordance with all applicable procedures.

·         *Accurately perform external data reconciliation in accordance with all

·         applicable    procedures. Accurately perform case report form annotation.

·         Provide input to, generate and distribute status reports as required, ensuring their accuracy.

·         Represent Data Management at internal / external meetings as appropriate.

·         Serve as a mentor for other staff in Data Management, and provide input to the performance appraisal process as requested.

·          Undertake other reasonably related duties as may be assigned from time to time.

Qualification

Minimum of a Diploma or Degree in a Scientific discipline or locai equivalent. or equivalent work experience as described in Section 3 of this document.

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.