Manager - IT - III* - Calsoft Labs
Raleigh, NC 27609
About the Job
The role of the Manager IT – III, would work collaboratively with the Associate Director, Business Analysis R&D IT, business units such as Regulatory Affairs, Medical Affairs, Quality, Supply Chain, Vendors and other Information Technology (IT) entities to meet project deliverables and timelines.
Provide support in the gathering, reviewing, and analyzing of data to inform business decisions, and document user requirements, business processes, and problems to improve existing systems; elicits and document business needs for new systems. Analyzes program policies and procedures to determine their effect on automated systems and system functional areas. Defines scope and objectives, creates system specifications that drive system development and implementation, among other duties.
• Interact with the business to support the implementation of systems and applications, while also providing ongoing support for new module implementations and/or installation of new capabilities
• Comply with Software Development Lifecycle and company's Computer Systems Validation (CSV) process and procedures
• Actively participate in all phases of application implementation, including ownership of key deliverables such as Change Controls, User Requirements Specification, Function Specification, Design Specifications, Risk Assessments and Validation documentation
• Deployment & Hypercare support
• May provide assistance in business case development (i.e., research, data collection).
• Support development of user test cases, user stories and system integration testing and validates test results during testing.
• Participate in the review and approval of test plans, and monitors testing process to ensure that business results are adequately tested with minimal risk.
• May participate in the execution of test cases.
• Identify and recommend areas of process improvement
• Perform knowledge transfer and provide ongoing leadership, to support project go-live and beyond, operations and support activities.
Experience in a Business Analyst capacity would be beneficial, specifically within Research and Development IT, Regulatory Affairs /Technical Operations in Biotech, Oncology, or Clinical applications (Pharmaceutical / Life Sciences environment preferred but would consider candidates from another regulated industry)
In-depth knowledge of relevant systems and platforms (e.g., Veeva Vault, RIMS, Submissions, IDMP, etc.)
Experience working with data visualization and AI platforms (Tableau, Power BI, Gemini, AWS, Copilot, etc.) is a plus.
• Manage multiple assignments with limited oversight, meet deadlines, and work well in a team environment
• Interacts with staff at all levels in a fast-paced environment, remaining flexible, resourceful, and efficient, with a high level of professionalism and confidentiality
• Ability to assume full responsibility for accuracy and reliability of complex analyses
• Track record of excellent task management skills such as planning, prioritization, meeting management and plan execution
• Effective verbal and written communication skills.
• Ability to understand the business needs and translate that into a solution that can be leveraged by multiple customers
• Should be able to adapt communication style to suit different audiences
• Effective facilitation skills.
Preferred Requirements:
• Bachelor's degree in Information Systems, Business Administration, Computer Science, or other related field of study.
• Master's degree plus 3 years of experience in related field of study as equivalent alternative.
• Minimum of 5 years of relevant technical or business work experience with in-depth knowledge of business operations and systems requirements processes.
Provide support in the gathering, reviewing, and analyzing of data to inform business decisions, and document user requirements, business processes, and problems to improve existing systems; elicits and document business needs for new systems. Analyzes program policies and procedures to determine their effect on automated systems and system functional areas. Defines scope and objectives, creates system specifications that drive system development and implementation, among other duties.
• Interact with the business to support the implementation of systems and applications, while also providing ongoing support for new module implementations and/or installation of new capabilities
• Comply with Software Development Lifecycle and company's Computer Systems Validation (CSV) process and procedures
• Actively participate in all phases of application implementation, including ownership of key deliverables such as Change Controls, User Requirements Specification, Function Specification, Design Specifications, Risk Assessments and Validation documentation
• Deployment & Hypercare support
• May provide assistance in business case development (i.e., research, data collection).
• Support development of user test cases, user stories and system integration testing and validates test results during testing.
• Participate in the review and approval of test plans, and monitors testing process to ensure that business results are adequately tested with minimal risk.
• May participate in the execution of test cases.
• Identify and recommend areas of process improvement
• Perform knowledge transfer and provide ongoing leadership, to support project go-live and beyond, operations and support activities.
Experience in a Business Analyst capacity would be beneficial, specifically within Research and Development IT, Regulatory Affairs /Technical Operations in Biotech, Oncology, or Clinical applications (Pharmaceutical / Life Sciences environment preferred but would consider candidates from another regulated industry)
In-depth knowledge of relevant systems and platforms (e.g., Veeva Vault, RIMS, Submissions, IDMP, etc.)
Experience working with data visualization and AI platforms (Tableau, Power BI, Gemini, AWS, Copilot, etc.) is a plus.
• Manage multiple assignments with limited oversight, meet deadlines, and work well in a team environment
• Interacts with staff at all levels in a fast-paced environment, remaining flexible, resourceful, and efficient, with a high level of professionalism and confidentiality
• Ability to assume full responsibility for accuracy and reliability of complex analyses
• Track record of excellent task management skills such as planning, prioritization, meeting management and plan execution
• Effective verbal and written communication skills.
• Ability to understand the business needs and translate that into a solution that can be leveraged by multiple customers
• Should be able to adapt communication style to suit different audiences
• Effective facilitation skills.
Preferred Requirements:
• Bachelor's degree in Information Systems, Business Administration, Computer Science, or other related field of study.
• Master's degree plus 3 years of experience in related field of study as equivalent alternative.
• Minimum of 5 years of relevant technical or business work experience with in-depth knowledge of business operations and systems requirements processes.
Source : Calsoft Labs