R&D IT Systems Analyst – Clinical & Regulatory

Alkermes; Waltham (MA); On-site; USD 105,000 - 119,000; Full time

Job summary

Alkermes is seeking a Sr. Systems Analyst for the R&D IT team. This role collaborates with Development, Clinical, Regulatory and Medical teams to evaluate, implement, enhance and support current systems, and to optimize data capture, aggregation and analysis for research activities.

You will work with scientists to identify key data sets, implement the required infrastructure, and translate business needs into scalable IT solutions while complying with GxP, cybersecurity and regulatory standards.

Qualifications

• Bachelor’s degree in Computer Science, Information Systems, Engineering or equivalent.
• 5-8 yrs experience supporting discovery, clinical, regulatory, medical organizations
• Experience in the pharmaceutical/biotech industry strongly preferred
• Hands on working knowledge of Veeva systems
• Investigates new technologies (and/or changes to existing technologies)
• Good understanding of system integrations, automation, data flows
• Understanding of statistical data analysis and visualization platforms
• Experience working within a GxP regulated environment
• Working knowledge of Linux platform and some scripting
• AWS experience is helpful
• Core Competencies:
• Partner with vendors, external and internal stakeholders to support solution design and delivery
• Good verbal and written communication skills to effectively express ideas, provide updates to technical and non-technical audiences
• Actively Listen, value all opinions and facilitates open discussion across all functions
• Problem solving skills to understand and troubleshoot issues
• Displays flexibility and creativity in problem solving and meeting work assignments while ensuring compliance with policies and procedures
• Travel Requirements:

Responsibilities

• Work with stakeholders to understand their business processes, requirements and data flows using various elicitation techniques
• Create and update all software lifecycle documentation
• Partner with cross functional teams including R&D, Infrastructure, Validation, QA, vendors
• Develop and manage vendor relationships, coordinating configurations, upgrades, releases, request management and support activities
• Lead data migration and curation projects as needed throughout the R&D organization
• Analyze gaps, recommend opportunities for improvement that fit the business needs
• Coordinate issue resolution with internal and external technical support providers
• Prioritize tasks between strategic initiatives, ongoing system releases and day to day activities
• Ensures adherence to regulatory requirements, cybersecurity standards, department policies, procedures and SOPs
• Build and foster effective relationships between the business stakeholders and IT
• Oversee vendor relationships for implemented systems and solutions
• Ensure adherence to FDA computer systems validation compliance

Skills

Systems analysis

Data analysis

Regulatory knowledge

GxP compliance

Linux

AWS

Education

B.S. in CS/IS/Engineering

Tools

Veeva Systems

Job description

Alkermes is seeking a Sr. Systems Analyst for the R&D IT team. This role collaborates with Development, Clinical, Regulatory and Medical teams to evaluate, implement, enhance and support current systems, and to optimize data capture, aggregation and analysis for research activities.

You will work with scientists to identify key data sets, implement the required infrastructure, and translate business needs into scalable IT solutions while complying with GxP, cybersecurity and regulatory standards.