Senior Clinical Business Analyst

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

• Medical, dental, and vision insurance beginning Day 1 of employment

• Flexible work schedules

• Attractive PTO plan

• Engaging employee programs

• Remote working

What you'll be doing:

Creation and delivery of requirement specification for software by:

• Understanding the unique needs of the Imaging Business Units
• Reading, comprehending and being able summarize and communication appropriate actions on various study documents (i.e. 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 document the design of the requirements to ensure that study documents are appropriately followed and mapped efficiently and accurately
• Routing and managing review of requirements for scientific teams, project teams, client configuration teams and other stake holders
• Creating, maintaining, and storing requirements for study-specific internal or external products or services
• Assisting in training, mentoring and requirements review for Clinical Business Analyst Team
• Maintaining and developing standard requirements, templates, and libraries to promote efficiency and improvements
• Working with stakeholders and apply thorough understanding of the operational process, software and science to identify and address areas of efficiency and improvements
• Functioning as a subject matter expert to advise on software process, requirements development and gathering best practices
• Managing and promote collaboration to foster a positive environment with the stakeholders to effectively communicate potential risks, mitigations, and escalations as appropriate
• Creating and distribute reports

Supports Development and Validation by

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

Supports Medical & Scientific Affairs by

• Providing guidance and clarification to the Medical & Scientific teams on the requirements
• Providing guidance to Medical & Scientific teams for development and updates of study documents to ensure alignment to software
• Providing feasibility review to determine scope, effort and required actions needed for novel medical therapeutic criteria and assessments
• Attending internal and external meetings to understand software needs and expectations

Supports Product Management by

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

Supports Clinical Project Management and Operations Departments by

• Providing guidance and clarification to the Project Management teams on the requirements
• Participating in internal and external meetings to communicate the management of the software build process and address client concerns and questions
• Collaborating with Project Management teams on study timelines and change in study scope
• Providing end user training and act as SME for support
• Attending Study Kick-off Meetings for new projects
• Supporting process and change requests

Supports Clinical Data Management by

• Ensuring consistency between trail 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
• Attending internal meetings to address data and data capture queries and concerns

Maintains Quality Service and Departmental Standards by:

• 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 to achieve results
• Performing other duties as assigned

Maintain technical and industry knowledge by:

• Attending and participating in applicable company-sponsored training
• Maintaining a strong understanding of industry trends and applicable technology

Qualifications:

Education

• Bachelor’s degree in a related field is required (2+ years relevant experience and training at Clario may be considered in lieu of a degree)

Experience

• Minimum of 5 years’ experience as a Medical Writer, Project Manager, Clinical Business Analyst or other position working collaboratively across business stakeholders, technology organizations and customers in a global environment
• Previous clinical trial experience and a working knowledge of clinical trial process preferred
• Previous experience with medical imaging preferred
• Experience in developing configuration specifications for software applications highly desirable
• Experience working with computer software including the MS Office suite

Additional skill set:

• Ability to work in group setting and independently
• Ability to adjust to changing priorities
• Ability to organize and prioritize assigned tasks to meet established schedules, timelines, or deadlines
• Problem solving abilities
• Strong interpersonal and communication skills (both verbal and written)
• Excellent attention to detail and meticulous work
• Ability to maintain a professional and positive attitude

Working conditions:

Travel: 0-5%

Lifting: 0-100 lbs

Other: Computer work for long periods of time

This position description should not be deemed all inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.

EEO Statement

Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

The duties and responsibilities listed in this job description represent the major responsibilities of the position. Other duties and responsibilities may be assigned, as required. Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract.