Work as Clinical Data Programmer in 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
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.

Post: Clinical Data Programmer - 043714

Job Description
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.

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.
  • 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.

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