Operations Solution Engineer

JOB TITLE:      Operations 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

Operations 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 may assist with the development and documentation of processes and procedures.

KEY ACCOUNTABILITIES(maximum 10)

1. Collaborate with other Solution Engineers, and others as determined, to ensure questionnaires, clinical trial protocol, and overall designrequirements are understood and can be implemented as well as analyse the protocol/scope to collate the design requirements for simple to moderate complexity projects.
2. Produce functional requirements documentation based upon design requirements shared by Senior and/or Lead Solution Engineer, as necessary.
3. Utilize all available tools and information sources to understand requirements, including interviews/meetings, document analysis, use cases and workflow analysis.
4. Update and mange requirements/specifications as needed throughout the software development lifecycle. Follows defined validation processes and produces validated documents for all questionnaires.
5. Evaluate information gathered from multiple sources, work with stakeholders to reconcile conflicting information, identify/evaluate potential risks and translate abstract or high-level requirements into useful/actionable implementation.
6. Ensures best practices and standards are followed in every implementation.
7. Liaise with Localization to facilitate the development of translated versions of the master questionnaire (This is Rater Station Specific)
8. May be responsible for application configuration.
9. They provide support for SDLC and validation documents as well as facilitate the review and approval of all documents. (This is Rater Station Specific)

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. Own the design elements of the questionnaires and system requirements.
2. Responsible to identify and communicate risk.
3. Responsible for establishing best practices for creation of questionnaire, system requirements, integration specifications, and overall design.
4. Impact to end-user experience
5. Impact to data integrity
6. Interface with internal and external teams, including sponsors.

KNOWLEDGE, SKILLS & ATTRIBUTES

Essential (maximum 10):

1. Bachelor’s degree or equivalent years of professional role.
2. 2-3 years’ experience functioning as Business Analyst or similar role.
3. In depth experience with Software Development Life Cycle (SDLC) implementation
4. Gathering information from a wide variety of sources and subsequently crafting it into effective and audience-appropriate technical and non-technical documentation.
5. Excellent analytical and problem-solving skills and a desire to solve problems.
6. Ability to resolve conflicts between people and competing goals and interests.
7. Desire for developing one’s own skills:  technical, clinical, and interpersonal.
8. Have good communication abilities via writing, quality documentation and presenting in meetings. Delivers information effectively and timely. Uses interpersonal skills to build and develop relationships with internal and external team members.  
9. Needs to be an effective, positive team player, and a self-starter, with moderate level of guidance and direction.
10. Must have very strong skills with Microsoft Office application to include the following: Word, Excel, Visio and PowerPoint

Desirable (maximum 5):

1. Software development background/experience
2. User experience/interface degree/experience
3. Familiarity with GCP and 21 CFR Part 11 is a plus
4. 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