Clinical Data Programmer (Oracle INFORM & Central Designer)

About ICON

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 Data programmer

Type of Employment           : Full Time

Location                               : ICON PLC, INDIA - Chennai ?Bengaluru / Trivandrum

Responsibilities:

• 2+ year of Experience in Central Designing is Must
• Serves as the lead on study specific database design within the CDMS system (i.e. Oracle RDC, Oracle Inform, Medidata Rave, DataTrak UX EDC, Oracle Clinical and CRF Work Manager),
• leading clinical database programming activities on multiple studies of simple to moderately complex design and expert in all areas for relevant CDMS. ·
• Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
• Builds clinical study database CRF screens per CRF Specifications provided by project team.
• Creates/Programs edit checks, special actions/functions, custom programs and derivations as per a DVS.
• Plans and schedules edit check test script writing, edit check programming and edit check validation with the centralized CDMS Testing group and centralized CDMS Programming group.
• Manages timelines for edit check process, ensures issues are addressed in a timely manner to meet timelines and produces edit check validation packages for delivery to the study teams to file in the Trial Master File.
• Completes study database updates as specified per Change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes
• Configures study specific data interfaces such as IVRS, labs, and CTMS.
• Serves on project teams to coordinate and lead CDMS activities for clinical database programming projects. 
• Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverable, and provides constructive criticism.
• Keeps those responsible for project management informed of any issues that might impact project target dates, scope or budget and escalates potential problems effectively and in a timely manner.
• Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.
• Trouble-shoots and solves study building issues and/or system integration issues (such as IVRS fa ilures, CTMS issues), and/or change request issues using the appropriate applications.
• Creates advanced CDMS custom programs as per DVS, as required .
• Ensures high quality deliverables by providing review of study-level/program -level I multi- study core deliveries for accuracy.
• Attends sponsor audits and assists with in-progress audits, including presenting the CDMS process and procedures and presenting the validation documentation produced by the CDMS group.
• To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features. Participate in Data Management department initiatives.
• Plan for the study execution in detail thereby providing clarity on all aspects of the setup progress (Round 1 programming date, testing dates, UAT dates)
• To act as a brid e between the Clinical Data Programmers and Validation within CDMS. Addressing technical clarifications and providing guidance as needed.
• Maintaining all necessary study documentation for the CRF build and edit checks.
• Keeps up-to-date with all software developments and release notes of assigned primary CDMS system. Research and self-training is required to ensure that CDMS knowledge, particularly in relation to system functionality, is current.
• Ensures all queries to the CDMS group are responded to in a timely manner, particularly when trouble-shooting an issue or answering a system functionality question.
• Ensures that queries that cannot be resolved are routed to the correct SME and the issue is pursued until resolved.
• Contributes to training materials on a process, system or technology level. Works with ICON University and Management on delivery of training courses, instructor-led and on-the-job.
• Ensures programming processes are compliant with applicable SOPs.
• Ability to retrieve raw data sets.
• 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