Ref #: 33063

Employment type: Permanent - Full-Time

Location: Chennai/ Bangalore

Posted: 18-Oct-2021

Description

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

POSITION SUMMARY:

Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. These tasks are to be performed independently or team based with minimal
guidance and supervision.

Description:
Provide study level expertise and involvement in Clinical Trial Team.
Develop SAS listings and BO/J-Review Reports for various line functions, used for ongoing monitoring
of clinical data.
Peer/technical review clinical programming activities;
Provide understandable and actionable reports on clinical data and monitoring of clinical data for key
stakeholders.
Facilitate interaction with end-user on creating specifications and working with programmers or
performing the programming activities for successful delivery.
To provide quantitative analytical support to the global program teams, including providing support on
analyzing reports.
Support the planning, execution and close-out of Clinical Programs/Trials.
Support the management in collation and delivery of analytics reports for critical decision making.
Create, file and maintain appropriate documentation.
Work with the internal SMEs and key stakeholders in providing analysis and interpretation of clinical
program/trial operational data.
Provide necessary training to end-user on best / appropriate and consistent use of various data review
tools.
Program reports of various complexity from documented requirements, within the clinical reporting
systems using SQL, PL/SQL, C#, VB script, SAS, Python, R.
Good Knowledge of Clinical Data Standards and its implementation for creation of reports
specifications or reports output.
Lead or provide support to special projects both clinical and non-clinical in nature or in general areas
spanning various responsibilities but not limited to systems issues, processes, user support, training,
etc.

To be successful in the role, you will have:

Strong knowledge of programming languages (SQL, PL/SQL, C#, VB script, SAS, Python, R)
Strong knowledge of Data Review and/or Business Intelligence tools (such as JReview, Business
Objects)
Knowledge of clinical data management systems and/or relational databases (e.g. OC/RDC,
INFORM, RAVE) as applied to clinical trials
Ability to translate technical concepts for non-technical users in the areas of clinical database design
and data review reporting development
Understanding of Drug Development Process, ICH-GCP, CDISC standards and Health Authority
guidelines and regulations
Knowledge of regulatory guidelines in relation to data quality and clinical trials conduct.


Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

To apply:

Would you like to know more? Please submit your CV to Kalpana.Kulasekaran@docsglobal.com