“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 14000+ employees across the
globe. ICON is a $2bn company having its presence across 97 offices in 38 countries.
Job Title
: Clinical Data Lead
Reporting
to
: Sr Manager, DM
Type of
Employment : Full Time
Location
: Chennai, office based
Position Summary
Job Description Summary
The lead data
management point of contact for day to day activity on a study with key
responsibilities for study set-up and close-out tasks as well as overseeing and
coordinating tasks delegated to the study team members both locally and in
other offices, reporting to the Data Management Project Manager
Job Description
- Recognize, exemplify and adhere to ICON's values which centers
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 10% domestic/international
- Read, ensure
understanding and adhere to all assigned ICON SOPs and working procedures
- Ensure all work performed is of high quality, compliant with
Good Clinical Practice, ICH Guidelines and all applicable laws and regulations
- Complete all assigned
training (including the Study Lead Development Program) and courses in the ICON
Training Management system (iLearn); ensuring that mandatory courses are all
completed before the designated date and that the required system specific
training has been completed for current studies
- Record all billable and
non-billable time in the appropriate timesheet management system (e.g.
Planview™)
- Take part in study kick off (internal and external) meeting
along with the DMPM
- Read, ensure understanding
and adhere to the stud protocol, contract and scope of work for all task during
set-up, maintenance and close-out of the study
- Review all activity on an ongoing basis to identify out of scope
tasks and bring to the attention of the DMPM and Contract analyst
- Assist in compiling the change order log for review by the DMPM
- Develop an understanding
of the revenue recognition and revenue forecasting process
- Assist the DMPM with revenue recognition and revenue forecasting
process on a monthly basis
- Lead the development of specifications, implementation, and
testing for the eCRF or paper CRF
- Lead the development of
specifications, implementation, and testing for the edit checks and data review
and oversight listings (DVS)
- Lead development of the
data management plan and study specific procedures
- Ensure effective
implementation of standard metric and status reporting on the study
- Lead development of
specifications for custom reporting on the study
- Perform project planning tasks and support the DMPM in the
development of the project plan and timelines
- Set up and maintain data management study files for inclusion in
the Trial Master File, ensuring these are maintained in an audit ready state
for review by Sponsor, Regulatory or ICON Auditors
- Adhere to ICON SOPs, the Data Management Plan and study specific
procedures in the implementation of tasks on the study
- Adhere to the project plan and timelines in the implementation
of study tasks during set-up, maintenance and close-out of the study
- Key point of contact for the sponsor and the study team on day
to day study data issues, eCRF design, edit checks, and other implemented
components
- Organize and lead regular data management team meetings, both
internal and with the sponsor and the DMPM
- Attend and provide an
update for data management services at cross-functional study team meeting both
internally and with the sponsor and the DMPM
- Maintain and track meeting minutes, issues and decisions logs,
and escalations
- Support the DMPM in
negotiation of time lines and decision making on the study
- Provide regular study status update to the DMPM
- Support the DMPM in the
delivery of study specific training to all team members, ensuring that the
training is documented and the documentation filed in the Data Management Study
files
- Assess the training needs of study team members on an ongoing
basis
- Provide refresher training to team members as required
- Provide feedback to the DMPM on issues with study team member
performance
- Support the DMPM in the
delivery of training to cross-functional study team members both
Experience required
- A
minimum of 7 years’ experience in Data Management
Academic or Trade qualifications:
Any life science
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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