EDC / Medidata RAVE System Designer / Programmer (System Designer / Analyst IV)
Company: Alpha Consulting
Posted on: March 17, 2023
EDC / MEDIDATA RAVE SYSTEM DESIGNER / PROGRAMMER (SYSTEM
DESIGNER / ANALYST IV) 100% Remote. Project Description:
- The Client is looking for Quality driven EDC/Medidata RAVE
- Not Manager or oversight 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.
- 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 vendor on data acquisitions and peer review
of deliverables and maintain technical interface with external data
- 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. Required Skills:
- Bachelor's Degree with 5 + years of demonstrated ability in
Clinical Research, Computer Science, Project Management, or related
- Strong knowledge of research and development, clinical trials
execution, and understanding of regulatory requirements/guidelines
(e.g., ICH, GCP, safety reporting).
- Strong knowledge and understanding of regulatory guidelines for
the use of computerized systems in clinical trials.
- Strong knowledge of global standards related to clinical
programming activities (CDASH data standards, database design,
coding, and coding dictionaries, etc.).
- Should have hands on experience in EDC/Medidata RAVE clinical
database & setting up EDC/Medidata RAVE studies and program edit
checks/dynamics per specifications and accountable for on time
- Able to read, understand the protocol and transcribe into the
- 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
- Have a Good understanding about CDASH/CDISC terminology and
global standard objects and common data standards used during
- Consider having with Project Data manager skillset with hands
on designing experience of EDC/ Medidata RAVE databases for
clinical studies. Any other designing tool Veeva EDC, SQL, other
programming language, understanding rational database would be plus
for this role.
- Strong ability to work in a matrix environment and communicate
effectively with different functional groups across the
- Strong ability to foster open communication and practice active
listening to encourage a collaborative team environment.
- Demonstrates a solution-oriented approach to problem solving
and a "can do attitude.
- Veeva EDC Study Build Experience a big Plus. This 12+month
position starts ASAP. This position has a minimum hourly pay of
70.34 and a maximum hourly pay of 86.00 (Pay rate depends on State
of Residency). Please E-MAIL your resume (attachment to email) with
rate and availability to Bridget: ALPHA'S REQUIREMENT #23-00400
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Keywords: Alpha Consulting, Eugene , EDC / Medidata RAVE System Designer / Programmer (System Designer / Analyst IV), Professions , Remote, Oregon
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