Nonclinical Data Associate
Laboratory Corporation of America Holdings (Covance)
Madison, Wisconsin, United States
Nonclinical Data Associate
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 group in Madison, WI.
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.