Assistant Clinical Data Programmer

3 weeks ago

Thiruvananthapuram, India ICON Full time

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

**Job Description**:

- 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.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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