Clinical Trial Role

Job Title: Clinical Trial Role
Location: 1-2x onsite in Rockville, MD 20850
Client: Pharma domain
Visa: USC, GC, EADs, H1B
Exp Level: 15+ years

Job Summary
We are seeking an experienced, hands-on IT Business Partner (ITBP) to bridge the gap between our IT organization and our business department, especially engaged with the teams under R&D, such as Biostatistics, Clinical Operations, Regulatory, etc. In this role, you will act as the key liaison, translating business needs into robust, compliant technical solutions.

The ideal candidate possesses deep domain expertise in biopharma IT ecosystems, including eTMF, EDC, CTMS, RTMS, SAS, QMS, etc., and combines rigorous project management discipline with the technical agility to drive implementations from inception to validation.

Key Responsibilities

1. Business Partnering & Strategic Alignment
   Work closely with the IT head, serve as the IT point of contact and advisor for Clinical Operations, Biostatistics, Medical Writing, QA and Regulatory Affairs.
   Proactively identify opportunities where technology can optimize system and process execution, data analysis, and regulatory submissions.
   Cascade IT strategies, roadmaps, and project updates clearly to business stakeholders and leadership.

2. Hands-on Project Management & Delivery
   Lead end-to-end IT projects from business requirements gathering, process design, solution sourcing & selection to deployment, hyper-care, and system retirement.
   Define project scope, create detailed project plans, manage timelines, allocate resources, and mitigate risks within the part-time schedule.
   Maintain a highly organized project portfolio, delivering regular status reports and interactive presentations to the stakeholders.
   Hands-on Execution: Actively participate in system configuration, data migration planning, user acceptance testing (UAT) coordination, and the creation of user guides/cheat sheets.

3. Clinical Systems Management & Compliance
   Oversee and optimize the clinical IT ecosystem, ensuring seamless integration and data flow across platforms among the Clinical Ops, Biometrics & Analytics, Medical Writing, Medical Safety, and so on.
   Ensure all software deployments, upgrades, and integrations comply with regulatory standards, specifically FDA 21 CFR Part 11, GxP, and data privacy laws (GDPR/HIPAA).
   Partner with Quality Assurance to author and execute validation lifecycle documentation (IQ/OQ/PQ).

Qualifications & Requirements

Education & Experience
Experience: Minimum of 5 years of experience in IT Project Management or Business Analysis, specifically within the Biotech, Biopharma, or pharmaceutical industries.
Domain Knowledge: Proven track record of successfully implementing and managing clinical trial systems, QMS and supporting biostatistics/programming environments (SAS, R/Shiny).

Technical & Compliance Competencies
Strong understanding of the drug development lifecycle and clinical operations workflows.
Solid grasp of GxP software validation processes and FDA 21 CFR Part 11 compliance requirements.
Experience navigating cloud-native architectures (e.g., Microsoft Azure, AWS) and secure cloud storage solutions (e.g., Box) is highly desirable.

Soft Skills & Work Style
Communication & Presentation: Exceptional verbal and written communication skills; ability to convert complex technical terms into clear business language for cross-functional partners.
Time Management: Well-organized ability to prioritize, multi-task, and manage multiple concurrent workstreams efficiently within a part-time framework.
Execution Focus: A distinct "hands-on" mentality—willingness to roll up your sleeves to troubleshoot issues, write documentation, and support end-users directly.