• Clinical Data Programmer Jobs in Chennai,India - 23296327

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Job Description:

Clinical Data Programmer (Oracle INFORM & Central Designer)

India-Chennai; India-Trivandrum


Reference 058633


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 $1575bn 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


2 year of Experience in Central Designing is Must
Serves as the lead on study specific database design within the CDMS system (ie 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 competitors and pharmaceutical companies, we provide more flexible and reasonable working platforms for coaching and educating new comers 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//wwwiconplccom/ or careersiconplccom


Technical and competency selection

When you spot an opportunity youre 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


After this, well let you know if well 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


If youre 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

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Biotechnology/Pharmaceutical/Medicine
Functional Area : IT Software : Software Products & Services
Role : Software Engineer
Salary : As per Industry Standards
Deadline : 01st Feb 2020

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