Sr Clinical Data Programmer
About the role
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Hello,
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 : Sr.Clinical Data Programmer (SDTM)
Type of Employment : Full Time
Location : ICON PLC - Chennai INDIA
Position Summary
· 5-7 years of experience in study specific database set-up within at least one CDMS system
· Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
· Builds clinical study database CRF/database screens per CRF/database Specifications provided by Clinical Data Programming Leads.
· Creates/Programs edit checks, special actions and derivations as per a DVS.
· Works closely with centralized CDMS Validation Group to ensure all programming issues are resolved in a timely manner and study timelines are met
· Completes and maintains all study documentation as per ICON procedures
· Completes study database updates as specified per Change Request documents and procedures.
· Trouble-shoots and solves study building issues and edit check programming issues.
· May participate in study team meetings as an ad hoc study team member.
· Attends sponsor audits and assists with in-progress audits, as needed.
· To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features . Participate in Data Management department initiatives.
· Ensures all queries are responded to in a timely manner. Ensures that queries that cannot be resolved are routed to the correct SME and the issue is pursued until resolved.
· Ensures programming processes are compliant with applicable SOPs.
· Ability to retrieve raw datasets
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.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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