Skill: research , clinical data , oracle clinical , validation , clinical study , edc , clinical , data management , crf , medidata rave; Exp: 0-3 years; Sr Clinical Data Programmer India-Chennai Permanent Reference 052132 Description Recognize, exemplify and adhere to ICON’s values which center around our commitment to People, Clients and Performance. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. * Travel (approximately 15 PERCENT ) domestic and/or international. CDMS * Serves as the lead on study specific database design within the CDMS system (i.e. Oracle RDC, Oracle Inform, Medidata Rave, DataTrak UX EDC, Oracle Clinical and CRF WorkManager), leading clinical database programming activities on multiple studies of complex design and expert in all areas for relevant CDMS. *Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS). *Builds clinical study database CRF screens per CRF Specifications provided by project team. *Creates/Programs edit checks, special actions/functions , custom programs and derivations as per a DVS. *Plans and schedules edit check test script writing , edit check programming and edit check validation with the centralized CDMS Testing group and centralized CDMS Programming group. Manages timelines for edit check process, ensures issues are addressed in a timely manner to meet timelines and produces edit check validation packages for delivery to the study teams to file in the Trial Master File. *Completes study database updates as specified per Change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes *Configures study specific data interfaces such as IVRS, labs, and CTMS. *Serves on project teams to coordinate and lead CDMS activities for clinical database programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism . Keeps those responsible for project management informed of any issues that might impact project target dates, scope or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. *Trouble-shoots and solves study building issues and/or system integration issues (such as IVRS failures , CTMS issues), and/or change request issues using the appropriate applications. Creates advanced CDMS custom programs as per DVS, as required. May participate in study team meetings as an ad hoc study team member to advise study team on best approach/tool for data collection, to determine scope and limitations of the study and to discuss edit checks, derivations , testing and reports. Ensures high quality deliverables by providing senior review of study-level/program -level I multi study core deliveries for accuracy. Participates in special projects or tasks related to the assigned CDMS as directed by the CDMS Manager, as required. This can involve taking ownership of planning, maintenance and delivery of special projects while keeping management informed of the progress. Attends s onsor audits and assists with in- ro ress audits , includin the CDMS rocess A Svrnbol of Excellence and procedures and presenting the validation documentation produced by the CDMS group. *Maintain confidentiality of management information as appropriate. To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features. Participate in Data Management department initiatives. Plan for the study execution in detail thereby providing clarity on all aspects of the setup progress (Round 1 programming date, testing dates, UAT dates) To act as a bridge between the Clinical Data Programmers and Validation Group within CDMS. Addressing technical clarifications and providing guidance as needed. Maintaining all necessary study documentation for the CRF build and edit checks. Keeps up-to-date with all software developments and release notes of assigned primary CDMS system.
Function: Biotech / Pharma / R&D