Design Documentation Analyst 1 at Signant Health

Key Accountabilities/Decision Making & Influence

• Perform a technical review of requirements to provide suggestions according to set standards regarding typos, order, clarity, conciseness, style, and terminology.

• Edit, proofread, standardize, and recommend changes to existing artifacts prepared by other authors within the Business Systems Analysis (BSA) group.

• Drives consistent high product quality through the institutionalization of the requirements review process.

• Works closely with Business Development, Project Managers and Business Systems Analysts and Technical Delivery to scope project complexity, clarify requirements and provide guidance to the relevant team members about project risks.

• Ensures that requirements have been traced forward from protocol to system design, and that they are complete,

• Works with BSA and Technical Delivery to confirm that requirements can be implemented in design.

• Proactively identifies testing risks based on requirements and design.

•  Reviews the impacts of protocol amendments on requirements.

•  Responsible for managing the documentation of product standards (Template and Branch Flows).

• Other projects and responsibilities as needed and determined by manager.

• May design system functionality and/or create systems requirements to support core product development and / or enhancement as business needs dictate.

•  May recommend and advise on edits but understands the author has final ownership of content and format within established standards.

• Travel: 5% or less and may include International travel.

Diversity and Inclusion Competencies

• Dedication and commitment to promote diversity, multiculturalism and inclusion in all work activities

• Ability to collaborate in diverse teams to foster productive outcomes.

Knowledge, Skills & Attributes

• Must have excellent interpersonal, verbal, and written skills and be able to establish/maintain a positive working relationships with both technical and non-technical personnel.

• Ability to communicate verbally and in writing clearly and succinctly, with analytical and problem-solving skills with proven ability to comprehend complex project plans, design and technical issues, as well as business and product requirements.

• Working knowledge of a System/Software Development Life Cycle (SDLC).

• Must have demonstrated ability to simultaneously manage multiple ongoing projects of varying scope, varying timelines, take direction from multiple inputs, and complexity with minimal supervision.

• Must be detail-oriented and able to successfully plan, prioritize, execute, and track tasks and responsibilities in order to meet established individual and group deadlines.

• Strong organizational, time-management, analytical, and decision-making skills in order to efficiently evaluate, plan and accomplish personal work goals.

• Demonstrated experience coordinating or supporting complex and/or software development projects is highly desirable.

• Proven ability to successfully handle multiple competing priorities and deliver on-time project results with little direct supervision.

• Must have very strong skills with Microsoft Office application to include the following: Word, Excel, Visio and PowerPoint.

• Familiarity with GCP and 21 CFR Part 11 is a plus

Desirable:
 

• Bachelor’s degree or equivalent years of experience.

• 1+ years experience functioning as IT Business Analyst or similar role.

• Minimum of two (2) years technical writing experience.

• Familiarity of Information Technology terminology as well as medical/clinical trial terminology a huge plus.

• Understanding of clinical trials through prior experience in a Clinical Research Organization (CRO), or within the Biotechnical and/or Pharmaceutical industry desirable.