Clinical EDC Programmer / SDTM Oversight

Company: Alpha Consulting Corp.
Location: Lexington
Posted on: May 28, 2023

Job Description:

CLINICAL EDC PROGRAMMER / SDTM OVERSIGHTLEXINGTON, MA Remote. Pay range 131.23 - 136.85.W-2 Candidates only, H1B Visa Transfer available. Project Description: The Clinical / EDC Programmer works closely with Data Management as well as a multidisciplinary project team across the life cycle of a study to coordinate and support technical aspects of EDC build, including Rave Custom Function development, Business Objects report development and SAS programming tasks related to data cleaning and reporting. The Clinical /EDC Programmer attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. A successful candidate will keep those responsible for project management informed of any issues that might impact project target dates, scope, or budget and will escalate potential problems effectively and in a timely manner. The Clinical / EDC Programmer balances multiple task assignments and communicates needs to supervisor to obtain needed resources. He or she interfaces with clients and vendors as needed to support system integrations (e.g., IRT/Rave integrations, TSDV implementation). Reviews and specifies requirements for Rave module integrations (e.g., Coder); facilitates cross-functional team discussions around such integrations, sets up and maintains these integrations; leads validation efforts for Rave integrations, incorporating the cross-functional team as needed. Reviews and specifies requirements for novel EDC integrations (e.g., Rave, and external IWRS integration, Rave/ePRO integration), facilitates cross-functional team discussions and/or discussions with external vendor team around such integrations, sets up and maintains these integrations, leads validation efforts for integrations, incorporating the external vendor team as needed. Participates in UAT/Validation tasks related to EDC build, metrics report programming, and data listings. Consults on study design, as needed, from systems integration perspective. Serves as technical support for Rave EDC build, including custom function programming. Contributes as needed to support Clinical Data Managers with additional study-build activities, including form, edit check, and study structure. Leads the Business Objects and/or SAS programming tasks associated with project-specific metrics reporting, working across the project team to ensure final reports meet the needs of all internal and external stakeholders. Leads the SAS programming tasks to convert EDC data and metadata into formats/structures needed for other systems. Performs oversight of externally created SDTM datasets and accompanying documentation, ensuring compliance with company and Industry standards for SDTM data. Required Skills: BS/BA in Life Science, Computer Science, or related discipline. 7+ years of clinical data management and/or statistical programming experience in the pharmaceutical/CRO industry. 5+ years of Electronic Data Capture programming (EDC) experience including: Medidata Rave EDC and Coder. Business Objects. ODM based integration of external systems via Rave Web Service API. 5+ year experience in SAS programming for clinical reporting needs. 5+ years' experience programming or oversight of raw to SDTM data creation. Strong working knowledge of FDA & ICH/GCP regulations and guidelines. Strong knowledge of CDISC (CDASH/SDTM), medical dictionary coding standards, FDA, and ICH guidelines, GCP, 21 CFR Part 11, Clinical Data Management best practices. Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment. Experience with DIA TMF reference model pertaining to CDM documentation. Certified Medidata Rave Architect with C# Custom Function development experience Ability to program reports and external edit checks using SAS Ability to oversee and ensure compliance of externally mapped SDTM datasets and accompanying documentation as per NN and Industry standards. This 12+month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com ALPHA'S REQUIREMENT #23-00926MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE PDN-99253ced-36e7-442c-a92a-da1cb5a63959

Keywords: Alpha Consulting Corp., Boston , Clinical EDC Programmer / SDTM Oversight, IT / Software / Systems , Lexington, Massachusetts