Senior Business Systems Analyst - IRT

JOB TITLE:   Operations Senior Solution Engineer

REPORTS TO TITLE:   Associate Director or Manager, Delivery Management, Global Technical Delivery

BUSINESS FUNCTION/ SUB-FUNCTION:  Global Technical Delivery

LOCATION:Worldwide

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ROLE PURPOSE

The Operations Senior Solution Engineer is responsible for working with Sponsors/Customers, Clinical, Global Project Management (GPM), Data Management and across the matrixed Global Technical Delivery (GTD) to design solutions for clinical trials utilizing Signant Health’s product portfolio. They analyse study protocol requirements and define solutions considering scientific guidance, electronic clinical outcome assessment (eCOA) best practices and Signant’s products and standards. They play a key role in ensuring the project meets the study needs and is feasible to implement, based upon the capabilities and limitations of the product, in the quoted timelines and budget. They are responsible for understanding business needs and translating them into system requirements.  They provide support for SDLC and validation documents as well as facilitate the review and approval of all documents.  They may assist with the development and documentation of processes and procedures.

KEY ACCOUNTABILITIES (maximum 10)

1. Analyse the protocol and scope to collate the design requirements.
2. Liaise with Commercial and GPM to understand up-front conversations with sponsors and expectations, then with Science and/or Clinical to initiate the solution definition
3. Collate questions and design options to be presented to the sponsor, providing recommendations, design alternatives and background to best practices to ensure the right choices are made.
4. Analyse and communicate design risks and options to mitigate against them, if possible. This includes any Change in Scope related to any new feature or design update. Communicate proactively with the implementing teams to ensure the implementation of the solution progresses as planned and the solution is implemented according to standards and best practices.
5. Lead the design portion of internal/external meetings to confirm design requirements with sponsors and gather any additional, critical business needs making sure Standards are followed for moderate to considerably complex projects.
6. As applicable, document design decisions in user stories and collaborate within GTD team to accept user stories for implementation.
7. Seek feedback on their designs proactively, through involvement of internal and sometimes external stakeholders and in regular design board meetings.
8. May be responsible for application configuration.
9. Facilitate and manage the review and approval of test results, and all SDLC and validation documents. (Rater Station Only)

Data Extract and Reporting (Rater Station Only)

1. Creation of Data Extract requirements and associated deliverables for project.
2. Assist in posting of data extract deliverables for projects. 
3. Creation of Custom Report requirements and deliverables

DECISION MAKING AND INFLUENCE

1. eCOA/RTSM design expert owning the design elements of the solution.
2. Responsible to identify and communicate risk.
3. Through collaboration with implementing teams, the role has an influence on the overall design outcome of the study.
4. Impact to end-user experience
5. Impact to data integrity
6. Interface with internal and external teams, including sponsors.
7. Effectively coach and counsel business users on issues that they might encounter.

KNOWLEDGE, SKILLS & ATTRIBUTES

Essential (maximum 10):

1. Bachelor’s degree Technology Science, Life Science, other appropriate subject, or equivalent years of experience
2. 3-5 years’ experience functioning as Business Analyst or similar role.
3. Demonstrated experience in developing complex solutions or software for use in clinical research with extensive experience in requirement elicitation and documentation, experience in Jira preferable.
4. Excellent analytical and problem-solving skills and a desire to solve problems with the ability to resolve conflicts between people and competing goals and interests.
5. Ability to lead difficult conversations constructively.
6. Provides guidance to junior staff and has influence on functional strategy.
7. Desire for developing one’s own skills:  technical, clinical and interpersonal.
8. Ability to instil confidence in others, e.g., when recommending solutions to sponsors
9. Have good communication abilities via writing, quality documentation and presenting in meetings.
10. Needs to be a self-starter, effective, positive team player. 

Desirable (maximum 5):

1. Software development background/experience
2. User experience/interface degree/experience
3. Agile/Lean Six Sigma experience
4. Familiarity with GCP and 21 CFR Part 11 is a plus
5. Familiarity with SQL Queries is a plus

ROLE DIMENSIONS

Direct Reports: 0

Indirect Reports: 0

Travel:  Up to 15% International Travel

Budget Responsibility: N/A

OTHER INFORMATION

N/A