Sumitomo Pharma America, Inc. · 10 hours ago
Manager, R&D Applications
United States
Full-time
Remote
Mid, Senior Level
$127K/yr - $159K/yr
7+ years expSumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in various health domains. They are seeking a Manager for Clinical Systems R&D IT Business Applications who will act as the primary liaison between the R&D Clinical Operations team and IT, responsible for delivering and supporting technology solutions that align with business needs and operational demands.
Pharmaceuticals
Responsibilities
Partner with Clinical business stakeholders to co-create technology plans which support their business objectives and operational demands
Continuously assess current systems environment and identify changes (process and/or system) that enhance effectiveness
Assist in the evaluation of new technology systems and/or service providers
Oversee end-to-end management of IT projects—including planning, design, and implementation—ensuring projects are delivered on time, within scope, and with measurable business impact
Work with a team of managed service providers supporting the lines of business technology needs including project delivery, solution design, enhancement requests and support services
Accountable for managing clinical application systems through their full lifecycle, from implementation to ongoing optimization
Lead and initiate troubleshooting quality and/or functionality issues associated with technology systems in scope
Develop and maintain comprehensive project documentation, ensuring centralized storage and accessibility for knowledge management
Manage and prioritize system enhancements and fixes in collaboration with business stakeholders
Provide regular project status reports, manage issues proactively, and adjust schedules as needed while maintaining alignment with the overall program plan
Responsible for timely execution of all GxP system commitments and compliance activities (Backup recovery, Disaster Recovery testing etc.)
Collaborate with cross-functional IT teams to ensure seamless delivery of services, efficient communication, and shared accountability for outcomes
Establish clear performance metrics and service level agreements (SLAs) to monitor IT service delivery, project outcomes, and stakeholder satisfaction
Stay informed of emerging industry trends, best practices, and regulatory changes to proactively recommend technologies and process adaptations that empower the company during phases of rapid expansion
Serve as the IT subject matter expert for application upgrades, integrations, and system enhancements across supported business areas
Qualification
Required
Proficiency in implementing, integration, and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment
Strong understanding of Clinical business processes, requirements and technology systems supporting Clinical Trials (e.g. EDC, CTMS, ETMF, Payments etc.)
7+ years of progressively increasing experience managing clinical applications in a Pharma/Biotech company
Strong understanding of building and operating a technology support function
BS/BA degree in a related discipline is required
7+ years of experience in life sciences with a focus on IT system delivery
5+ years of experience in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment
Experience in Program & Project Management, including the Software Development Lifecycle and Computer Systems Validation process
Excellent communication skills
Preferred
Training or equivalent experience in IT or business management is beneficial but not required
Benefits
Opportunity for merit-based salary increases
Short incentive plan participation
Eligibility for our 401(k) plan
Medical, dental, vision, life and disability insurances
Leaves provided in line with your work state
Flexible paid time off
11 paid holidays plus additional time off for a shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter
Company
Sumitomo Pharma America, Inc.
Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and CNS.
Founded in 2023Marlborough, Massachusetts, US
1001-5000 employeesH1B Sponsorship
Sumitomo Pharma America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (9)
2023 (14)
Funding
Current Stage
Late StageLeadership Team
Adele Gulfo
Chief Executive Officer, Biopharma Commercial
Myrtle Potter
President and Chief Executive Officer, Sumitomo Pharma America
Company data provided by crunchbase