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.
Post : Clinical Data Programmer
Job Description
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.
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.
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.
• *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
• *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
Candidate Profile
Minimum educational degree requirements: Bachelor’s degree in Life science
Minimum educational degree requirements: Bachelor’s degree in Life science
Additional Information
Qualification : Bachelor’s degree in life science
Location :Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 10th December, 2018
Qualification : Bachelor’s degree in life science
Location :Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 10th December, 2018
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