IT Project Manager
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Role details
Tech stack
Job description
Lead the technical implementation and optimization of clinical, regulatory, and quality platforms. Translate R&D business objectives into compliant technical requirements and system designs. Manage high-level project plans and execution workstreams within a lean biopharma environment. Execute technical validation protocols and author IQ/OQ/PQ documentation for regulated systems. Troubleshoot complex application issues and provide direct support to clinical operations teams. Develop technical user manuals, system documentation, and instructional training materials. Facilitate stakeholder follow-up and coordinate technical deliveries across R&D and Medical Safety. Founded in 1999, Resourcesoft, Inc. is a leading Technology Consulting and Professional Services organization. Headquartered in Marlborough, MA, the company serves the technology needs of its clients nationwide. Resourcesoft has often been recognized by prominent rating agencies for its exemplary growth and stability. With over two decades of industry experience, the Company has evolved as a front runner in enabling project optimization. We partner with leading organizations to provide technology solutions within the financial, insurance, education, government, publishing, healthcare and pharmaceutical domains. We take pride in mentoring a workforce that is well positioned to respond to the emerging IT trends and needs. With the employees at the crux of every business endeavor, our success is driven by our expertise in pairing the right talent with the best jobs in the technology sector. We forge long term, personalized relationships with our employees to advance their career to the next level. We engage them in technology centric client projects that provide opportunities for them to evolve, innovate and deliver world class products and services. Our career opportunities offer challenging assignments and exposure to emerging and cutting edge technologies. We are committed to providing our employees with the tools necessary to accelerate their career progression, while maintaining a healthy, work-life balance. We are deeply committed to providing a workplace ambience that is both challenging and fulfilling.
Requirements
5+ years of experience in Life Sciences IT project management and systems analysis. Proficiency in R&D and clinical platforms including eTMF, EDC, CTMS, and QMS. Experience with GxP validation, FDA 21 CFR Part 11, and IQ/OQ/PQ documentation. Experience with SAS, R/Shiny, and RTMS technical environments. Experience in leading User Acceptance Testing (UAT) and system validation cycles. Experience with secure cloud collaboration tools such as Microsoft Azure, AWS, and Box. Excellent verbal and written communication skills for effective R&D stakeholder management.
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