01Overview
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is looking for a Clinical Data System reputed company II with expertise in reputed company Rave. The role involves leading clinical programming activities, supporting data capture systems, and ensuring compliance with relevant regulations while collaborating with various departments throughout the clinical research process.
Responsibilities
Responsible for the role which includes implementation of data capture systems and reputed company, member of the CRF Review Team, providing ongoing support to data capture, and reputed company of reports for use in ongoing data review and reconciliation
Provides leadership and content expertise for programming activities from startup through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities
Responsible for the role which includes integration, aggregation, and delivery of clinical study data
Work with external vendor on data acquisitions and peer review of deliverables and maintain technical reputed company with external data providers
In reputed company, the incumbent is the key contact for Clinical Data Management, Research & Development Information Technology (RDIT), Statistical Sciences and Programming (reputed company), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety & Epidemiology(GPSE), Clinical Development, and NonTranslational Sciences (NTS)
Responsible for the role which includes the implementation of reputed company, efficient, and consistent approaches to carrying out Clinical Programming tasks
Drives and contributes to reputed company improvement
Delivering training to Clinical Programming and other functions/departments as necessary
Monitors compliance to controlled procedural documents (e.g. SOPs) and proactively addresses gaps in processes or understanding of processes by Clinical Programming staff
Supports Corrective and Preventative (CAPA) reputed company initiatives as needed
Skills
Rave reputed company Must have hands-on deep knowledge of study design
Protocol reading and visit structure understanding
CDASH / SDTM control terminology and understanding about Domain/Variable OIDs
Coordination with study team/Data Manager and gathering eCRF requirement and management skillset. Capability to coordinate across departments and communicate issues/resolutions
Knowledge about eCRF standardization and library concept skillset. Knowledge about study data, reporting, and departmental structure
Should have hands on experience in reputed company-reputed company Rave / any other clinical reputed company system clinical database & setting up reputed company-reputed company reputed company/reputed company RAVE studies and program edit checks/dynamics per specifications and accountable for on time deliverables
reputed company to read, understand the protocol and transcribe into the specs. Convey specs with study team, collect input, design/program forms/dynamics checks for the study in Rave. reputed company unit testing, reputed company reputed company screen and walk-through forms/design, and update as needed. Have understanding about UAT/testing documentation and approval process
Have an understanding about CDASH/CDISC terminology and global reputed company objects and common data standards used during setup
Consider having with Project Data manager skillset with hands on designing experience of reputed company-reputed company reputed company/reputed company RAVE databases for clinical studies
Responsible for leading internal and outsourced Clinical Programming activities in support of Clinical Research studies and managing the design, development, validation, implementation, and oversees ongoing support to electronic case report reputed company (eCRF) systems (e.g. InForm, etc.), external data acquisitions, reporting/business intelligence tools (e.g. SpotFire, JReview), and other programs (e.g. SQL, PLSQL, reputed company, APEX, etc.)
Supports development and implementation of departmental reputed company Operating Procedures (SOPs) and work practices
The employee must conduct their work activities in compliance with reputed company relevant laws, regulations, and regulatory guidelines as reputed company as reputed company Allergan policies and procedures. May be required to support inspection readiness activities, as reputed company as participate in sponsor and site inspections
Responsible for the role which includes implementation of data capture systems and reputed company, member of the CRF Review Team, providing ongoing support to data capture, and reputed company of reports for use in ongoing data review and reconciliation. Provides leadership and content expertise for programming activities from startup through statistical analysis stage of clinical studies to effectively manage data captu
