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DOCS Data Standards Specialist-RAVE in Boston, Massachusetts

Data Standards Specialist-RAVE

Ref #: 29098

Employment type: Permanent - Full-Time

Location: United States - remote

Posted: 10-May-2021

Description

Hey Data Standards professionals! Looking for an exciting new position ICON/DOCS is recruiting for a home-based opportunity for our FSP program to work on Data Standards based in RAVE!

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:

• Develop and maintain Rave libraries that are utilized across all therapeutic areas and or within a specific therapeutic area.

• Developing global standards to be applied across trial design, phases and therapeutic areas

Responsibilities:

• Recognize, exemplify and adhere to client standards

• Read, ensure understanding and adhere to all assigned SOPs and working procedures (as appropriate).

• Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.

• Developing and implementing specifications for a Rave form

• Working with Architect Loader Spreadsheets (ALS) and uploading ALS to Rave

• Developing and implementing data validation rules for a Rave form

• Supporting the implementation of custom functions in Rave form

• Working with Rave Library Wizard

• Developing a User Acceptance Testing (UAT) plan and related test scripts for a set of Rave forms

• Executing UAT and reports accurately findings using reporter module in RAVE

• Provide the support to the TA leads

• Implement CDISC CDASH and SDTM standards

Qualifications:

• University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree

• Rave EDC experience and expertise

• CDISC CDASH and SDTM expertise

• Rave Standards development experience

• Handle multiple tasks and prioritize accordingly

• Ability to learn and use ad hoc tools (e.g. running SAS jobs) for expedited production

• Track record of delivering according to plan

• Has excellent communication skills, verbal and written

• Can work autonomously in a cross functional environment

• Cross Therapeutic area experience and working on Global libraries is desirable

• SAS LSAF and HPALM experience is desirable

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 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 through the form below.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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