Job Description

Company Information

Clario is a 50+ year old company that delivers industry-leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what’s possible. From new trial modes to faster and integrated evidence and findings, our innovative clinical trial solutions mean we can unlock better evidence.

What We Offer

• Competitive compensation
• Private health insurance
• Engaging employee programs
• Flexible work schedules
• Attractive PTO plan
• Flex workspace

Position Overview

We are seeking a detail-oriented individual to create and deliver requirement specifications for software, ensuring alignment with clinical trial needs and study documents. This role involves close collaboration with various teams, including scientific, development, validation, product management, and clinical operations.

Responsibilities

Software Requirements

• Creation and delivery of requirement specifications for software.
• Understanding the unique needs of the Imaging Business Units.
• Reading, comprehending, summarizing, and communicating appropriate actions on various study documents (e.g., Clinical Protocols, Imaging Charter, Procedures Documents, compliance reports) as related to software.
• Comprehending complex scientific, medical therapeutic criteria, assessments, and nuances as related to software.
• Gathering and documenting the design of requirements to ensure study documents are appropriately followed and mapped efficiently and accurately.
• Routing and managing the review of requirements for scientific teams, project teams, client configuration teams, and other stakeholders.
• Creating, maintaining, and storing requirements for study-specific internal or external products or services.
• Managing and promoting collaboration to foster a positive environment with stakeholders, effectively communicating potential risks, mitigations, and escalations.
• Creating and distributing reports.

Support for Development and Validation

• Providing guidance and clarification to the development and validation teams on requirements.
• Providing support for validation, UAT testing, installation, and deployment of software.
• Supporting the investigation and resolution of bugs and tickets when appropriate.

Support for Medical & Scientific Affairs

• Providing guidance and clarification to the Medical & Scientific teams on requirements.
• Providing guidance to Medical & Scientific teams for development and updates of study documents to ensure alignment with software.
• Attending internal and external meetings to understand software needs and expectations.

Support for Product Management

• Providing input and communicating department and software needs.
• Providing input to support defining enhancements and new features.
• Attending training sessions on new system features.
• Supporting the resolution of ServiceNow tickets when appropriate.

Support for Clinical Project Management and Operations Departments

• Providing guidance and clarification to the Project Management teams on requirements.
• Participating in internal meetings to communicate the management of the software build process.
• Collaborating with Project Management teams on study timelines and changes in study scope.
• Attending Study Kick-off Meetings for new projects.
• Supporting process and change requests.

Support for Clinical Data Management

• Ensuring consistency between trial data capture, data delivery, and database structures.
• Providing guidance on data mapping, data transfer format, and structure to ensure alignment with software.
• Providing guidance and clarification on requirements and software with respect to data delivery and data queries.

Maintaining Quality Service and Departmental Standards

• Reading, understanding, and adhering to organizational Standard Operating Procedures (SOPs).
• Participating in the modification of company SOPs related to the therapeutic team.
• Leading in the development of team SOPs, QRGs, and Work Instructions.

Secondary Responsibilities

• Maintain quality service and departmental standards by reading, understanding, and adhering to organizational standard operating procedures (SOPs).
• Contribute to team effort by working with internal staff to resolve issues, helping others achieve results, and performing other duties as assigned.
• Maintain technical and industry knowledge by attending and participating in relevant training and development activities.

Employment Type

Full time

Salary

[Salary information not provided]

Location Type

[Location type information not provided]