|
Search Jobvertise Jobs
| |
Jobvertise
|
Systems Analyst System Designer
Location: US-TX-Dallas
Email this job to a friend
Report this Job
Hlo Jobseekers, This is Madhav. I am a recruiter with Intellectt. We are currently looking for a Systems Designer/ Analyst IV at 100% remote(link removed) Please take a look at the details of the position and reply with your resume and expected hourly pay rate if you are interested. If you are not available in the job market can you please share any references from your end. Title: Systems Designer/ Analyst IV
Location: 100% remote
Duration: Longterm
Tax Terms: W2 or 1099 Job Description: - We are looking for EDC-Veeva CDMS/Medidata System Designer/Programmer. Not Manager or oversight role.
- Should have hands on experience in EDC-Veeva CDMS/Medidata RAVE clinical database & setting up EDC-Veeva CDMS/Medidata RAVE studies and program edit checks/dynamics per specifications and accountable for on time deliverables.
- Able 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. Perform unit testing, share EDC 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 standard objects and common data standards used during setup.
- Consider having a Project Data manager skill set with hands-on designing experience of EDC-Veeva CDMS/Medidata RAVE databases for clinical studies. Any other designing tool Oracle Central Designer/Inform, Veeva, Oracle PL/SQL, other programming languages, and understanding relational databases would be a plus for this role.
- 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 form (eCRF) systems (e.g., InForm, etc.), external data acquisitions, reporting/business intelligence tools (e.g., Spotfire, J Review), and other programs (e.g., SQL, PL SQL, SAS, APEX, etc.).
- Supports development and implementation of departmental Standard Operating Procedures (SOPs) and work practices.
- The employee must conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as all Allergan policies and procedures. May be required to support inspection readiness activities, as well as participate in sponsor and site inspections.
Key Duties/Responsibilities: - Responsible for the role which includes implementation of data capture systems and methods, member of the CRF Review Team, providing ongoing support to data capture, and generation of reports for use in ongoing data review and reconciliation. Provides leadership and content expertise for programming activities from start up 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 vendors on data acquisitions and peer review of deliverables and maintain technical interface with external data providers.
- In addition, the incumbent is the key contact for Clinical Data Management, Research & Development Information Technology (RDIT), Statistical Sciences and Programming (SSP), Global Clinical Trial Management (GCTM), Global Site Management Operations (GSMO), Global Patient Safety & Epidemiology (GPSE), Clinical Development, and Non Translational Sciences (NTS).
- Responsible for the role which includes the implementation of quality, efficient, and consistent approaches to carrying out Clinical Programming tasks. Drives and contributes to continuous 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) Action initiatives as needed.
Minimum Requirements: |
