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Testing Lead, Clinical Data


Location: Cambridge, Massachusetts
Job Category: Biotechnology



The Role:

This role is an exciting opportunity to be a critical part of Moderna’s growing Clinical and Medical Digital Systems team, supporting a high-growth organization that is radically changing the biotech industry.

Reporting to the Principal Project Manager, Clinical Informatics, the Test Lead will support the Testing activities across the Clinical Informatics Projects.

Here’s What You’ll Do:

Partner with clinical operations, data management, biostats, regulatory and safety to execute on Moderna leading edge digital and analytics strategy to support accelerated drug development.

Drive test development, estimation, planning, execution, reporting, and closure

Coordinate responsible test area with all the function of Clinical and Medical Digital Systems

Manage project schedules for responsible test area and draft UAT scripts as needed

Accountable for the quality of all work and relationships on their team

Create, monitor, and control metrics impacting product/project and team quality

Analyze product/projects quality and usability, associated system limitations, and report on risk

Host test closure activities, knowledge transfer, retrospectives

Develop training materials for project team and lead workshops for test leadership, requirements gathering, and risk identification

Coach and develop leadership talent across the department for succession planning

Champion and influence software development best practices and the customer experience always

Here’s What You’ll Bring to the Table:

At least 7+ years Experience in managing Pharma/Biotech domain projects – this should include planning, strategizing, execution and reporting-

Excellent communication and business interfacing skills – should possess the ability to work closely with multiple stakeholders

Should have strong leadership, analytical skills and ability to work in team in diverse/ multiple stakeholder environment

Good experience in Test Planning, Test tracking and Issue tracking using tools like Kneat, , JIRA or HP-ALM.

Good knowledge in R&D applications especially on Clinical and Regulatory systems

Should have worked on Analytics platforms such as Qlik, Spotfire, Looker or Tableau with big data

Experience managing team size of 2-3 would be a plus

Excellent verbal and written communication skills

Good understanding of GxP system validation process and procedure and data integrity requirements for systems used in the conduct of clinical trials.

Tangible track record in using Agile approaches for product development

A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

Bachelor's degree in Computer Science, Biotechnology or equivalent required. Master's preferred.

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