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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QUALIFICATIONS/EXPERIENCE 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).
CDMS:
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 .
CDS:
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.
Additional Information:
Location: Chennai
Organization: Data Management
Industry Type: Pharma/ Biotech/Clinical Research
Reference: 043714
Functional Area: CDP
End Date: 5th April, 2017
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