Job Title : Clinical Data Programmer (RAVE)
Job Location : Chennai / Bangalore / Trivandrum / Home-based (for the right candidate)
Job 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.
* Participates in study specific database set-up within at least one CDMS system (i.e. Medidata Rave, DataTrak UX EDC, Oracle Clinical and CRF WorkManager)
* Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS).
* Builds clinical study database CRF/database screens per CRF/database Specifications provided by Clinical Data Programming Leads.
* Creates/Programs edit checks, special actions and derivations as per a DVS.
* Works closely with centralized CDMS Validation Group to ensure all programming issues are resolved in a timely manner and study timelines are met
* Completes and maintains all study documentation as per ICON procedures
* Completes study database updates as specified per Change Request documents and procedures.
* Trouble-shoots and solves study building issues and edit check programming issues.
* May participate in study team meetings as an ad hoc study team member.
* Attends sponsor audits and assists with in-progress audits, as needed.
* To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features . Participate in Data Management department initiatives.
* Ensures all queries are responded to in a timely manner. Ensures that queries that cannot be resolved are routed to the correct SME and the issue is pursued until resolved.
* Ensures programming processes are compliant with applicable SOPs.
* Ability to retrieve raw datasets.
* Other responsibilities may be assigned as required.
Minimum 2 – 4 years of experience in Rave / Veeva.
Experience in custom function programming is mandatory