REMOTE - Associate Director, Software Quality Assurance

Job Overview:

The Associate Director, Software Quality Assurance provides leadership and subject matter expertise with respect to Quality Management for Clinical Systems as well as educate and influence clients and partners on the most effective ways to implement the snapClinical platform. The Associate Director, Software Quality Assurance helps ensure that company solutions are implemented and configured in accordance with defined standard business processes, meets client requirements and adhere to Good Clinical Practices. Works with clients to provide guidance and make suggestions on how to best implement product software to provide the most value. Works with Project Managers and Product Engineering during the implementation and configuration of the product platform for clinical studies, in addition to helping in the training, education and authoring specification documents as well as configuring study design during the development of clinical studies.

Primary Responsibilities:

• Advise clients and internal staff on best practices for implementing and integrating product software within a clinical ecosystem.

• Work with Project Managers in translation of customer needs in terms of clinical functionality to ensure a match between needs and actual system capabilities/limitations.

• Work directly with the client to prepare, adopt, or agree on all specifications provided by the client

• Ensure that Clinical Services functions are aligned and meet Project Management timelines and deliverables

• Assist in timely completion of quality deliverables

• Define and enforce data collection and handling standards on all deliverables to ensure consistency and facilitate downstream processing (e.g., QC testing)

• Coordinate and support product engineering during study development

• Support the creation of requirement documentation and user stories based upon client clinical system requirements, including functional test cases, for use in configuring and developing solutions as well as in custom integrations with other products.

• Lead and support training in preparation of course materials and delivery of courses both internally and externally (e.g., clinical sites and investigator meetings) as needed.

• Support custom integrations with clinical system to ensure final product meets customer requirements

• Support customer during user acceptance testing cycle by resolving issues, answering questions, and guiding them through the process

• Work with third party vendors such as central labs to ensure that all back-end clinical data changes follow best clinical data management practices

• Provide written and verbal status reports to management on client projects and internal projects

• Participate in internal initiatives, e.g., process improvement, product improvement, and identifying best practices

• To ensure quality releases, you will need to collaborate with product managers and embedded software engineers

Education/Qualifications:

BS in scientific or technical field

Experience:

Minimum 5 years in a Clinical Research role

• Provide leadership to Quality-managed programs, including:

• Quality Incident (QI) management reporting

• Supplier evaluation/audit

• Quality Assurance Document

• Internal Quality System audit (in coordination with department-led operational self-assessments)