Clinical Laboratory Technologist
ReignMarkconsultingservices
Hiring: IT Business Partner – Clinical Trials / Biopharma IT (C2C Contract)
Location: Rockville, MD 20850 (1-2 days onsite per week)
Hours: 28-32 billable hours per week
Employment Type: Contract
No Visa Sponsorship Available
Please apply only if you have direct Clinical Trials / Biopharma IT experience. Candidates without hands-on experience supporting clinical systems, regulatory environments, or pharmaceutical R&D organizations may not be considered.
If you are interested or know someone who is a fit, please share your updated resume to:
***email_hidden***
We are seeking an experienced IT Business Partner (ITBP) with strong Clinical Trial and Biopharma IT experience to serve as the strategic liaison between IT and business teams across Clinical Operations, Biostatistics, Regulatory Affairs, Medical Writing, and Quality.
This role is best suited for professionals who have successfully led implementations and support of clinical systems within biotech, biopharma, or pharmaceutical environments.
5+ years of IT Project Management / Business Analysis experience in Biotech, Biopharma, or Pharma
Strong understanding of Clinical Trial workflows and Drug Development lifecycle
Hands-on experience with clinical platforms such as eTMF, EDC, CTMS, RTMS, QMS, SAS, and R/Shiny environments
Experience managing end-to-end implementations, UAT, validation, integrations, and data migration activities
Strong knowledge of FDA 21 CFR Part 11, GxP validation, GDPR, and HIPAA compliance
Experience supporting IQ/OQ/PQ documentation and software validation processes
Exposure to AWS, Azure, Box, and cloud-native clinical ecosystems is highly preferred
Excellent stakeholder management and communication skills