This role will migrate the existing technical documents to Clario format and also to Polerion.

Work with software development and delivery teams to develop, execute and align testing processes to support the development and release of Clario's Operational Data Store.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Conduct reviews of system and documents to ensure high quality of deliverables in accordance with quality standards and SOPs. 

• Coordinate routine status meetings to facilitate communications, monitor workload, and provide forecasting guidance. 

• Assist in writing software requirements and design documents, test scripts and traceability matrices. 

• Create and maintain functional specifications for study-specific implementations of Clario products and services. Author test plans and summaries to support testing methodologies. 

• Monitor and review all project deliverable quality. 

• Execution of test scripts including detailed documented results and screen shots. 

• Work with others on the engineering team to conform to our SDLC. 

• Participate in customer audits and provide quality assurance expertise and direction to project. 

• Work with Delivery and R/D teams to define and implement processes related product quality, deliverable validation and UAT. 

• Maintain and execute automated test case.

OTHER DUTIES AND RESPONSIBILITIES:

• Strong analytics and problem solving capabilities. 

• Desire to be a key player on a small, growing team that is building some great products for clinical research. 

• Ability to execute and deliver to tight guidelines and schedules. 

• Ensure compliance with timely training completion/documentation. 

• Technical abilities such as SQL, AWS and Test Automation.

QUALIFICATIONS AND SKILLS NEEDED:

Education:

• BS/MS in Computer Science or related field.

Experience:

• Knowledge of computer systems validation requirements for clinical research technologies a plus. 

• Knowledge of FDA Regulations surrounding 21 CFR Part 11 and cGxP a plus. 

• Experience in build automation and test automation technologies a plus. 

• Strong overall experience working on development teams building enterprise web-based and large scale systems. 

• Experience testing SOA based applications a plus. 

• Previous experience in Agile, team-based product development is preferred.

• Experience with cloud-based and SaaS products is a plus. 

• Experience in the clinical research or healthcare industry is a plus. 

• Desire to be a key player on a small, growing team in scaling and operationalizing the delivery of premier services to support innovative, data driven eClinical solutions. 

• Ability to execute and deliver to tight guidelines and schedules. 

• Excellent verbal and written communication skills, including ability to communicate effectively in English.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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. The Department Head has the discretion to hire personnel with a combination of experience and education, which may vary from the above listed qualifications.