Job Description
The Senior Manager, IT R&D Business Analyst will drive the delivery of technology solutions and digital transformation initiatives within R&D and Quality. This role involves partnering with business stakeholders to understand processes, gather requirements, and translate needs into best-in-class technology solutions. The IT Lead will ensure systems are compliant, validated, and deliver measurable business value in regulated environments.
Position Responsibilities
Lead selection, implementation, and operations of IT systems supporting the R&D landscape
Build strong relationships across Clinical Operations, Regulatory, PV, Biostats & Data Science, Clinical Pharmacology, Medical Writing, and Submissions
Ensure seamless integration and optimization of R&D technologies from research through regulatory submissions
Implement analytics, reporting, and AI solutions in coordination with specialized IT teams
Oversee system validation and change control processes with internal/external partners and Quality teams
Ensure compliance with global GxP, privacy, and regulatory standards
Manage vendor relationships and supervise contractors as needed
$140k-$150k (based on experience level)
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:
Skills and Requirements
7-10+ years of experience in technology roles within the pharmaceutical industry (in Clinical and Regulatory Domain)
Proven track record in IT delivery supporting R&D applications and data management solutions (Veeva Quality, RIM, Safety, Pharmacovigilance)
Strong understanding of GxP environments and Computer System Validation (CSV) lifecycle
Bachelor's degree in information technology, Engineering, Life Sciences, or related field
Excellent communication and stakeholder engagement skills across all organizational levels - Experience with cloud-based and SaaS solutions in pharma
Exposure to emerging technologies such as AI/ML
Familiarity with systems like eTMF, CTMS, EDC, RIM, eCTD Publishing, PV databases, QMS, and scientific data repositories
Ability to manage vendor relationships and supervise contractors
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