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CDMS Support Consultant

inSync Staffing

Indianapolis, IN(remote)

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JOB DETAILS
SKILLS
1st Level Support, Acceptance Testing, Application Programming Interface (API), Biology, Biotech and Pharmaceutical, Case Report Form (CRF), Clinical Data, Clinical Data Management, Clinical Information Systems, Clinical Trial, Code of Federal Regulations, Computer Science, Consulting, Contract Research Organization (CRO), Customer Relations, Customer Support/Service, Data Collection, Data Quality, Detail Oriented, Electronic Data Capture (EDC), Electronic Medical Records, GCP (Good Clinical Practices), Health Informatics, Health Insurance, Information Technology & Information Systems, Integration Testing, Medical Record System, Middleware, Network Testing, Pay-Per-Click Advertising, Problem Solving Skills, Product Requirements Document (PRD), Quality Assurance Methodology, Regression Testing, Risk, Secure/SSH File Transfer Protocol (SFTP), System Integration (SI), Team Player, Technical Recruiting, Test Plan/Schedule, Test Requirements, Test Scripts, Testing, Unix Shell Programming, Validation Documentation, Validation Testing, Vendor/Supplier Evaluation, Vendor/Supplier Selection, eSourcing
LOCATION
Indianapolis, IN
POSTED
30+ days ago
Job Title: eSource CDMS Support Specialist
 
Location: Remote
 
Industry: Pharmaceutical
 
Job Description:
Theoris Services is assisting our client in their search for an eSource CDMS Support Specialist to add to their growing clinical data management team. Our client is seeking someone with strong experience in Veeva CDMS/EDC, eSource technologies (especially CRIO Direct Data Capture and EMR-to-EDC integrations), UAT/testing processes, and inspection readiness support.
 
Responsibilities:
 
  • eSource Post Go-Live Monitoring & Support
    • Track and monitor mapped EMR fields across sites using existing CDMS reports and CDB autochecks (including hypercare for newer trials).
    • Work with Reporting SMEs to build any additional study-specific reporting tools focused on API vendor accounts.
    • Summarize reporting tool options, when to utilize them, and help educate eSource team members on their availability.
    • Help ensure API connections are verified after PPC study changes to ensure integrations do not break. 
  • UAT & Site Testing Support
    • Assist with defined UAT process based on sites/site networks and data domains in scope.
    • Work with study build/eSource personnel and other stakeholders to ensure that test scripts are successfully executed and documented for each site or site network ahead of PRD API or site user access requests. 
  • Vendor & Platform Release Testing and/or Supporting Tool Evaluations
    • Support UAT testing cycles for Veeva and eSource vendor releases.
    • Execute UAT regression testing under defined test plans.
    • Document results and escalate failures appropriately.
    • Assist organization with CDMS environment API connection testing as needed if parallel connections cannot be supported by the vendor.
    • Support evaluation of new eSource vendors to understand platform functionality and differences between middleware capabilities/API endpoint utilization.
    • Review of any tools providing automated review of vendor build templates to EDC study shell for understanding and/or gaps in content review. 
  • eSource Study Initiation Surge Support
    • Provide surge capacity when multiple eSource studies enter build concurrently.
    • Attend study and status meetings as necessary when CRF-CRS staff are unable to attend.
    • Prepare validation artifacts and checklists as needed. 
  • Routine Escalation & Triage (Non-Critical)
    • Act as first line support for routine eSource testing and validation questions.
    • Filter and escalate only high risk or ambiguous issues to CRS SMEs.
    • Prepare summary slides to help communicate issues and impact given varying levels of technical understanding with CDMS functionality. 
  • Integration Support Activities
    • Provide support for CDMS integration activities as needed especially for those efforts using APIs or sFTP accounts.
    • Collaborate with internal resources including the new Atom5 resource to support integration workflows. 
  • Inspection Readiness Activities
    • Support inspection readiness activities as identified.
 
Requirements:
  • Education & Experience
    • Bachelor’s degree in Life Sciences, Health Informatics, Clinical Data Management, Computer Science, or a related field (or equivalent professional experience).
    • 3+ years of hands-on experience in clinical data management, EDC support, eSource implementations, or clinical systems integration within a pharmaceutical, biotech, or CRO environment.
    • Proven track record supporting Veeva CDMS/EDC, eSource platforms (CRIO preferred), EMR-to-EDC integrations, UAT/testing, and inspection readiness activities.
  • Technical Skills
    • Strong working knowledge of Veeva Vault CDMS / EDC (study environments, reporting, CDB autochecks, API connections, and post go-live monitoring).
    • Experience with eSource technologies, particularly CRIO Direct Data Capture and EMR/EHR-to-EDC data mappings and integrations.
    • Hands-on familiarity with API integration testing, connection verification, middleware, and sFTP processes.
    • Proficiency in UAT, regression testing, test script execution, result documentation, and validation artifact preparation.
    • Ability to use CDMS reporting tools and support the creation of study-specific reports.
    • Understanding of clinical trial data domains, site/network testing requirements, and vendor release cycles.
  • Core Competencies
    • Excellent troubleshooting and problem-solving skills for integration, testing, and post go-live support issues.
    • Strong attention to detail with a commitment to data integrity, compliance, and inspection readiness (GCP, 21 CFR Part 11, ALCOA+).
    • Ability to work independently on routine support tasks while appropriately escalating high-risk or ambiguous issues.
    • Outstanding communication and collaboration skills — able to explain technical CDMS/eSource concepts clearly to non-technical stakeholders and prepare effective summary slides.
    • Proven ability to provide surge support and thrive in a fast-paced environment with multiple concurrent study builds.
 
Best-In-Class-Benefits:
We are in the people business; treating people right is our ONLY priority. Theoris Services consultants are full-time employees with full benefits, including:
  • Robust Health Insurance
  • 401(k) plan
 
About Theoris:
Our goal is to Fuel Your Career! As a Theoris team member, you join a culture based on people-centered values and an environment that fosters both personal and professional growth. We build long-term relationships with our clients and our consultants. With over 30 years of building strong relationships in the industry, we’re uniquely positioned to make the right connections. This knowledge is used to find the right job placement. Our recruiting teams are experts dedicated to the information technology and engineering staffing space and are highly respected by our client base.

About the Company

i

inSync Staffing

We recognize the VMS program management team is our customer and needs to be serviced with integrity, so we built and continue to improve upon our delivery methods as we strive to provide the highest quality service possible. inSync Staffing’s management team recognized ten years ago the inevitable changes to the staffing industry being brought about by technology and the growing trend of Fortune 1000 corporations to outsource management of their contingent workforces to meet compliance and cost control goals. Rather than swim upstream against the changes, inSync Staffing has embraced MSP and VMS programs as our customers, not competitors. We asked program managers how they want to be serviced. The result of their input is that we have structured inSync Staffing as a recruiting and customer service organization, unlike traditional staffing companies who sell directly to the end client. Our delivery model allows us concentrates our resources on how to best supply candidates in a very competitive MSP/VMS program environment.
COMPANY SIZE
50 to 99 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2014
WEBSITE
http://www.insyncstaffing.com/default.html

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