Likely to oversee contingent workers and/or vendors; Likely to provide training/ Mentoring to others
Ensures accurate set-up of data transfer processing
Delivers assignments with quality and within timelines
Provides strong programming support to CDISC based e-submission. Develops, debugs, and enhances SAS/ SQL programs to support to support study data batch processing and oversight listings
Responsible to define case report forms (CRFs) and external (non CRF) data specifications in accordance with CDISC guideline and Teva standards.
Responsible to define data flow and additional startup activities related to study initiation
Responsible to perform, supervise and manage day-to-day activities associated with receipt of clinical (CRF and non CRF) and operational (when relevant) data in accordance with study timelines
Responsible to perform data handling activities/unblinding activities on an ongoing basis to ensure accuracy, reliability, integrity, consistency and completeness of the data prior to database lock and providing the final data to clinical programming and statistics after database lock
Your experience and qualifications
Bachelor’s + 10 years or Master’s + 8 years of professional experience in a pharmaceutical or clinical research setting as a programmer
Bachelor’s Degree/ Master’s Degree/ PhD in Science, Statistics, Information Technology or equivalent combination of education and related work experience.
Thorough understanding of Clinical data, SDTM IG and Pinnacle 21