IT Business Partner (R&D)
Tandym Group
Watertown, MA, United States
2 months ago
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Role details
Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Job source
Tech stack
Clinical Data Management
Oracle (Applications)
Information Technology
Data Management
Veeva
GXP
Job description
A biotechnology company is seeking an IT Business Partner- R&D in Massachusetts to support clinical technology initiatives across research and development functions. This role partners with clinical operations, biostatistics, and data management teams to align business needs with scalable, compliant IT solutions., * Partner with clinical operations, biostatistics, and data management stakeholders to align technology solutions with business needs
- Provide subject matter expertise on business processes and system workflows across clinical, quality, or regulatory Vault environments as applicable
- Support system implementation activities, including requirements gathering, solution design, configuration oversight, vendor coordination, testing, validation, and deployment planning
- Translate clinical business requirements into scalable, compliant IT solutions within regulated GxP environments
- Collaborate cross-functionally with clinical, regulatory, quality assurance, and external vendors to support successful project execution and inspection readiness
Requirements
- Experience serving as an IT Business Partner or Clinical Systems Lead within Biotechnology or Pharmaceutical environments
- Hands-on implementation experience with Vault-based platforms and Clinical Technology ecosystems
- Strong understanding of Clinical Operations, Biostatistics, and Clinical Data Management business processes
- Experience supporting regulated systems in GxP and 21 CFR Part 11 environments
- Demonstrated ability to lead cross-functional clinical IT projects from planning through implementation
Desired Skills:
- Familiarity with Risk-based Quality Management concepts, Clinical Risk Management workflows, and Portfolio Planning tools or processes
- Experience with Veeva Vault, Medidata, or Oracle Life Sciences
- Experience in emerging Biotech or Pre-Commercial organizations
- Strong stakeholder engagement and vendor management skills
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