Senior SDTM Programmer

Karnataka Bangalore, India    |     Other   |   Full-time
Job Reference: 2805 - Posted 05-Apr-2021

Role : Senior SDTM Programmer

Exp : 5+ years

 

The position

Your key responsibilities in the job will be to design and set-up of study database for clinical trials and do the mapping of clinical data and metadata from source system(s) to Clinical Data Warehouse (CDW) and finalize SDTM deliverables. You will share better practices on use of standards in alignment with Lead SDTM Programmer and Standards Specialist and provide Business support. You will have to maintain system related documentation and facilitate implementation of business processes introduced by the systems supported by Clinical Systems & Data Management (CS&DM). At times if required you will have to support Clinical Data Interchange Standards Consortium (CDISC) Current Solution support.

 

Senior SDTM Programmer is expected to be responsible to collaborate on agreeing to timeline for EDC build and design process, Provide study level, end to end program/project management for EDC activities using EDC build tool, build and configure the eCRFs including: eCRFs (Forms), eCRFs for external data, standards, rules (edit checks) and the underlying study structure to support the Business provided protocol, generate case report forms (eCRF) for review and approval of eCRFs, Clinical database development activities, including protocol review, CRF/eCRF design, database discrepancy criteria, database development and testing, Peer Review (if required), IVRS error log testing, EDT file updates, LNMT mapping finally facilitate database lock and executes change requests.

 

Qualifications

The below knowledge, skills and experience will be required for the position.

         M.Sc. / B.Sc. in Life Science or comparable degree in Computer Science, Information Technology clinical information management or equivalent qualifications

         Minimum 5-9 years of experience in pharmaceutical industry and preferably 5 years within clinical data management and hands on experience in Central Design

         Advanced knowledge of computer systems

         Expert knowledge with analysis and design of business processes and functional design within the area of drug development

         Knowledge of validation of computer systems

         Extensive experience with collaboration across professional and regional borders

         Experience with communication and presentations

         Experience in supervision and mentoring

         Regular participation in conferences/workshops

         Demonstrated experience with project management

         Profound knowledge of GxP and other guidelines within drug development