Clinical Data Programmer

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 Data Programmer

Type of Employment           : Full Time

Location                                 : Chennai (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.

CDMS:

• *Participates in study specific database set-up within at least one CDMS system (i.e. Oracle RDC, Oracle Inform, Medidata Rave, DataTrak UX EDC, Oracle Clinical and CRF WorkManager)

• *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.

•Other responsibilities may be assigned as required.

CDS:

• *Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets.

• *Create data set specifications per specified study requirements.

• *Program data sets per specification .

• *Validate data sets per the formal, documented QC process.

• *Create data programming specifications per specified study requirements.

• *Program clinical data programs per specification .

• *Validate clinical data programs per the formal, documented QC process.

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.