Clario. The Best of ERT & Bioclinica.

Team Leader, Product Software Quality

Job Location US-MA-Medford
Shift
Regular
Type
Regular Full-Time

Overview

Clario is looking to hire a Team Leader, Product Software Quality. In this role you will work with software development and delivery teams to develop, execute, and align testing processes to support the development and release of products under R&D Data Integration & Services Product Software Quality department.

 

Clario delivers the leading endpoint technology solutions for clinical trials. Through experience gained from over 19,000 clinical trials delivered in support of 870 regulatory approvals, Clario fuses scientific expertise and global scale into the broadest endpoint technology platform to enable pharmaceutical, biotech and medical device partners to transform lives. Through Trial Anywhere™, Clario has mastered the ability to generate rich evidence across all trial models: decentralized, hybrid and site-based clinical trials. With 30 facilities in nine countries across North America, Europe and Asia Pacific, Clario’s global team of science, technology and operational experts has been delivering the richest clinical evidence for nearly 50 years.

Responsibilities

Our Team Leader, Product Software Quality will

  1. Conduct reviews of system and documents to ensure high quality of deliverables in accordance with quality standards and SOPs.
  2. Coordinate routine status meetings to facilitate communications, monitor workload, and provide forecasting guidance
  3. Assist in writing software requirements and design documents, test scripts and traceability matrices
  4. Create and maintain functional specifications for study-specific implementations of ERT products and services. Author test plans and summaries to support testing methodologies
  5. Monitor and review all project deliverable quality
  6. Provide risk-based analysis on test coverage and execution
  7. Execution of test scripts including detailed documented results and screen shots
  8. Work with others on the engineering team to conform to our SDLC
  9. Participate in customer audits and provide quality assurance expertise and direction to project
  10. Work with Delivery and R/D teams to define and implement processes related product quality, deliverable validation and UAT
  11. Maintain and execute automated test case
  12. Mentor Senior Software Quality Engineer and Software Quality Engineer

OTHER DUTIES AND RESPONSIBILITIES:

  1. Manage software testing efforts to schedule and estimates to achieve project deadlines
  2. Strong analytics and problem solving capabilities
  3. Attend client meetings as subject matter expert related to product/delivery validation best practices
  4. Desire to be a key player on a small, growing team that is building some great products for clinical research
  5. Ability to execute and deliver to tight guidelines and schedules
  6. Ensure compliance with timely training completion/documentation
  7. Technical abilities such as SQL, AWS and Test Automation.
  8. Mentor Senior Software Quality Engineer and Software Quality Engineer

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. This job description and any attachments do not constitute or represent a contract.

Qualifications

What we seek - 

  • BS/MS in Computer Science or related field
  • Management experience preferred
  • 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
  • Strong overall experience working on development teams building enterprise web-based and large scale systems
  • Experience testing SOA based applications a plus
  • Ability to write complex SQL queries and the ability to analyze the SQL data are required
  • Previous experience in Agile, team-based product development
  • Experience with cloud-based and SaaS products
  • 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. All are welcome - join us!

 

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