Clinical Data Programmer

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[Multiple positions]

Reporting to                  : Manager

Location                         : Chennai/Bangalore/Trivandrum

The Clinical Data Programmer role is either part of the Clinical Data Management Systems (CDMS) group

involved in clinical database build and maintenance or the Clinical Data Services (CDS) group involved in clinical data receipt, programming and delivery .

The Clinical Data Programmer is responsible for supporting Clinical Data Programming Leads who serve as the lead on study specific database set-up and/or the Team Lead for the Clinical Data Programmers . This support consists of activities as related to building study databases such as programming of CRF design, database build, edit checks, system reports and configuring other system features .

The Clinical Data Programmer is responsible for supporting Clinical Data Programming Leads who serve as the lead on study specific programming set-up and  delivery . The Clinical Data Programmer is responsible for specifying, developing , validating and executing programs and generation of clinical data deliverables.

• 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.

• *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.

• *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.
• *Review  and  quality  assure  CRF,  data  set  and  programming  specifications,  program  code  and outputs.
• *Create and maintain study documentation as required, in accordance with ICON Standard Operating Procedures.
• *Execute programs and generate clinical data outputs to according to study/client requirements.
• *Participate in testing of clinical data system upgrades and documenting of test scripts when required.
• *Adhere to Data Management department quality control procedures.
• Liaise with other ICON functions & sponsors as needed.
• To undertake other reasonably related duties as may be assigned from time to time.
• *Contribute to department process improvements, SOPs and WPs
• Other responsibilities may be assigned as required.

• US/LATAM/CAN:   minimum 1 years of experience in building study databases (CDMS) or clinical data programming and delivery (CDS).
• EU/APAC:   Prior experience  in building study databases  (CDMS)  or clinical data  programming  and delivery (CDS).

• Experience in Oracle RDC, Oracle Inform, Medidata Rave, DataTrak UX EDC, Oracle Clinical or CRF WorkManager  required
• Ability to successfully manage multiple tasks and timelines.
• Ability to perform assigned tasks with moderate supervision .
• Ability to liaise professionally with team members.
• Team player with strong verbal and written communication skills.
• Demonstrated ability to learn new technologies, applications and techniques .
• Experience in the software development life cycle.
• Knowledge of clinical database concepts .

• Demonstrated ability to produce programmed clinical data deliverables (CDS only) .
• Ability to successfully manage multiple tasks and timelines .
• Ability to perform assigned tasks with moderate supervision.
• Ability to liaise professionally with team members.
• Team player with strong verbal and written communication skills.
• Demonstrated ability to learn new technologies, applications and techniques .
• Competent knowledge of the clinical data programming development  life cycle.
• Competent knowledge of clinical data programming concepts.
• Competent Knowledge of SQL programming desirable.
• Competent Knowledge of SAS programming.

Associate's degree in information systems, science or related discipline or relevant experience

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. 

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.

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.

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.