Nonclinical Data Associate - Remote Possible
Posted on: April 10, 2021
Job Overview: Nonclinical Data Associate - Remote Possible
Interested in Programming? Quality Control? Creating Datasets?
Software Validation? Communicating with Clients? Databases? We have
a great opportunity for a Nonclinical Data Associate to join our
Global Data Management Solutions team in Madison, WI, Greenfield,
IN or Somerset, NJ. Remote working arrangement is a possibility.
Covance's work in developing new pharmaceutical solutions has an
incredible impact on millions of lives worldwide. Be a part of this
life-saving work and help improve patients' lives while growing
your career. This is an entry level Nonclinical Data Associate
position with a primary function of drafting and finalizing
nonclinical datasets. In this role, you'll be responsible for
generating structured datasets that are visualized by both
Pharmaceutical companies and regulatory agencies to determine the
safety, efficacy, and potency of life saving treatment. Additional
duties include, but not limited to: + Performing quality control
review datasets using industry data standards using (e.g. SEND,
SDTM, SENDIG). + Utilizing study documents (e.g., protocol, report)
to gather information to prepare datasets. + May compile metadata
to populate databases supporting nonclinical safety assessment. +
May assist with software testing and validation activities:
including executing test scripts and maintaining documentation in
accordance with Covance Unified Systems Life Cycle (CUSLC)
methodology which complies with General Principles of Software
Validation issued by the FDA. + Addresses pharmaceutical client
inquiries on content of study datasets, prepares letters and client
communication. Bring your basic knowledge of office software (e.g.,
Microsoft-- Office, especially Word and Excel; Adobe-- Acrobat--).
Prior experience with analytical programming (R, SAS, Python), VBA
programming, XML schemas is helpful but not required. Include your
passion for detail, time management and organizational skills and
we'll supply the opportunity to work within an experienced and
highly skilled team. #LI-DZ1 Education/Qualifications: + Bachelor's
degree or equivalent experience in Computer Science, Informatics,
MIS, Science, or other related field. + Degree and/or experience in
technical writing, document production/publishing, and/or science
preferred. Experience: Minimum Required: + Basic knowledge of
office software (e.g., Microsoft-- Office, especially Word and
Excel; Adobe-- Acrobat--). + Attention to detail, time management
skills, and organizational skills. Preferred: + VBA programming,
XML schemas, or analytical programming (R, SAS, Python) experience.
+ Prior experience with SEND, STDM, General Principles of Software
Validation issued by the FDA. + Software validation experience.
Covance is committed to diversity in the workplace and is an equal
opportunity employer (Minority/Female/Individual with
Disability/Veteran/Sexual Orientation/Gender Identity). Your
confidentiality and privacy are important to us.
Keywords: Covance, Trenton , Nonclinical Data Associate - Remote Possible, Other , Somerset, New Jersey
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