R&D Programmer IV
Bangalore, India, 560064
Who we are
The opportunity
The Clinical Programming Lead Manager is responsible for managing timely and accurate execution of all start-up activities and milestone deliverables for all assigned clinical trial projects.Clinical Programming lead manager is responsible for data definition by working with CRO and Third Party Vendors (TPV) to ensure receipt of data in Teva data standard format, generating the database transfer specification (DTS), receiving and processing study related data. This position is also responsible for providing professional expertise and leadership through leading departmental tasks and taking initiatives in improving data management processes with focus on Data Operations activities.
How you’ll spend your day
- Manages multiple projects
- 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
- 8+ years of SAS Programming experience
Teva’s Equal Employment Opportunity Commitment