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

This role is responsible for the creation and delivery of requirement specifications for software solutions, ensuring alignment with clinical trial needs and study documents. The position involves close collaboration with various teams, including scientific, development, validation, product management, and clinical operations, to ensure software meets project requirements and industry standards.

Responsibilities

Software Requirements Specification

• Creation and Delivery:
  • Understand the unique needs of the Imaging Business Units.
  • Read, comprehend, summarize, and communicate appropriate actions on various study documents (e.g., Clinical Protocols, Imaging Charter, Procedures Documents, compliance reports) as they relate to software.
  • Comprehend complex scientific, medical therapeutic criteria, assessments, and nuances as they relate to software.
  • Gather and document the design of requirements to ensure study documents are appropriately followed and mapped efficiently and accurately.
  • Route and manage the review of requirements for scientific teams, project teams, client configuration teams, and other stakeholders.
  • Create, maintain, and store requirements for study-specific internal or external products or services.
  • Manage and promote collaboration to foster a positive environment with stakeholders to effectively communicate potential risks, mitigations, and escalations as appropriate.
  • Create and distribute reports.

Support for Development and Validation

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

Support for Medical & Scientific Affairs

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

Support for Product Management

• Provide input and communicate department and software needs.
• Provide input to support defining enhancements and new features.
• Attend training sessions on new system features.
• Support the resolution of ServiceNow tickets when appropriate.

Support for Clinical Project Management and Operations Departments

• Provide guidance and clarification to the Project Management teams on requirements.
• Participate in internal meetings to communicate the management of the software build process.
• Collaborate with Project Management teams on study timelines and changes in study scope.
• Attend Study Kick-off Meetings for new projects.
• Support process and change requests.

Support for Clinical Data Management

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

Maintaining Quality Service and Departmental Standards

• Read, understand, and adhere to organizational Standard Operating Procedures (SOPs).
• Participate in the modification of company SOPs related to the therapeutic team.
• Lead 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 to achieve results, and performing other duties as assigned.
• Maintain technical and industry knowledge by attending and participating in relevant training and professional development activities.

Employment Type

Full time

Location Type

Information not provided

Salary

Information not provided