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EDC / Medidata RAVE System Designer / Programmer (System Designer / Analyst IV)

Company: Alpha Consulting
Location: Remote
Posted on: March 17, 2023

Job Description:


  • The Client is looking for Quality driven EDC/Medidata RAVE System Designer/Programmer.
  • 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 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. Required Skills:
    • Bachelor's Degree with 5 + years of demonstrated ability in Clinical Research, Computer Science, Project Management, or related field.
    • 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 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 a Good understanding about CDASH/CDISC terminology and global standard objects and common data standards used during setup.
    • 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 organization.
    • 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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