Data Managers Position Available In Allegheny, Pennsylvania

Pittsburgh, PA
1 DAYS AGO
21513232
Summary
Pittsburgh, PA
Competitive Salary
36 Months Experience
Bachelor’s degree
No Commisssion
40.00 hours per week / Day Shift /Full-Time
Description NSABP Foundation, Inc. seeks Data Manager in

Pittsburgh, PA Duties:

Serve as the primary internal and Sponsor contact for Data Management questions, issues, or concerns, including data collection, data cleaning, data delivery, data reconciliation, and database lock data management activity timeliness.
Responsible for Data Management Development, including define study requirements; participate in protocol specific EDC and database development; Design, develop and modify data infrastructure to accelerate the processes of data analysis and reporting, evaluate the design, selection and implementation of database changes by comparing them with business requirements and design documents; define standard edit checks and update as needed; develop Query Guidelines; and collaborate with internal teams to develop study setup requirements.
Assist with the development, review and finalization of data transfer requirements.
Serve as primary point of contact for query management, including establish a query dashboard to track performance; routinely review query dashboard to identify and analyze trends; collaborate with internal and external teams to resolve queries; resolve Sponsor or Site reported issues; create and review Data Archives for Sponsors and Sites; and ensure data management files are up-to-date and comprehensive, including data management plans, file specifications, data correction forms and requests, client emails.
Act as primary host for data management inspections and partner audits, and guides inspection readiness activities at clinical trial sites.
Develop and maintain data management plans, audit plans, risk assessments, corrective and preventive action plan.
Direct and perform audits and data verification to assess compliance with clinical trial standard operating procedures, FDA regulations, ICH guidelines and other regulatory bodies. Telecommuting permitted 2 days per week within the MSA.

Requirements:

Position requires a Bachelor’s degree in Mathematics, Statistics, Informatics or a related field, plus 3 years of experience in a related role. This role requires 3 years of experience with the following:

• Research experience working with industry clinical trials.
• Understanding of modern databases and information technologies.
• Metadata Rave, Marvin or REDCap.
• Regulatory standards, FDA and GCP for industry trials.
• Protocol specific EDC and database development.
• Training with the various clinical trial databases used for data collection.

40 hours/week. Must also have authority to work permanently in the U.S. Applicants who are interested in this position may apply at https://www.jobpostingtoday.com/ Ref # 48875