“At ICON, it's our People that set us Apart”
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
Type of Employment : Full Time
Location
: Chennai
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 .
CDMS:
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
.
CDS:
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.
Job Responsibilities
•
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.
Requirements
• 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.
Qualification
Associate's degree
in information systems,
science or related
discipline or relevant
experience
Benefit Working with ICON:
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.
PROCESS
Technical and competency selection:
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.
Interview
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.
Offer
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.
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