Validation Lead Details

Validation Lead

Science 37 - Seattle, WA

Employment Type : Full-Time

This is a fully Remote and Work From Home (WFH) opportunity within the US
Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. Backed by venture investors such as Glynn Capital, Google Ventures, Redmile Group, dRx Capital and Lux Capital, we are revolutionizing the clinical trial industry, one patient, at a time. To help us achieve our goal, we are seeking a Validation Lead, Analytics eager to make an impact within a mission-driven organization.

The Validation Lead, Analytics is responsible for developing and managing quality and evidence based validation processes used within the development lifecycle as it is specifically applied to data and analytics infrastructure and deliverables. As a lead, this role is responsible for defining approaches to meet the quality expectations of standard and custom deliverables, guiding the team in their application and use, and providing support for quality assurance within the team. This role will create validation assets and then work closely with individual Data & Analytics team members to ensure that assets and processes are selected and applied appropriately. The ideal individual will be adept at creating an environment that assures efficient, high quality output balanced with the controls and evidence needed to support reviewer confidence.
DUTIES AND RESPONSIBILITIES
Duties include but are not limited to:

• Create and maintain quality/validation/testing processes and artifacts as appropriate

• Coach the team members in the proper use of validation assets and execution of processes

• Evaluate deliverables and support the assessment of validation activities required

• Develop and/or support the development of validation plans, qualification test protocols, traceability matrices, reports, Installation and Operational Qualification protocols, and all documents and deliverables within the scope of the validation plan

• Execute or oversee the execution of validation plans and validation documents

• Review system requirements and specifications to ensure requirements are testable and quality requirements are met

• Incorporate risk-based methodology into the team quality approach

• Provide direct support for User Acceptance Testing

• Act as the quality representative for the Data & Analytics team

• Coordinate and represent audits of data infrastructure and data related deliverables

• Work with project manager to include validation activities in implementation timelines

• Ensure initiation/preparation and closeout of all validation related deviations, discrepancies and change control documents.

• Conduct or facilitate team quality training as needed

QUALIFICATIONS & SKILLS
Qualifications

• Bachelor's degree (B.A./B.S.) or equivalent in computer science, scientific or related discipline

• 5-7 years experience in Computer System Validation or IT Quality Assurance roles

• Experience working in a GxP clinical research environment

• Demonstrated ability to apply risk-based approaches

• Familiarity with General Data Protection Regulation (GDPR) and its impact on QA

• Comprehensive knowledge of regulatory requirements, including GxPs, Part 11, as they pertain to computerized systems

• Experience with high volume, small scope deliverable projects preferred

• Excellent organizational and analytical skills

• Demonstrated ability to shift priorities to meet a constantly changing environment

• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above

Skills/Competencies

• Strong interpersonal skills, and the ability to communicate and manage well at all levels of the organization

• Action oriented and innovative; able to guide the team with clear validation processes

• Strong collaborative team player, an advocate and monitor in the QA space

• Ability to effectively handle multiple tasks and ability to adapt to changes in workload and priorities

• Excellent planning, prioritization, and organizational skills

• High level of integrity and dependability with a strong sense of urgency and results-orientation

Capabilities

• Ability to communicate in English (both verbal and written)

REPORTING
The incumbent reports to the Sr. Director, Data & Analytics, who will also assign projects, provide general direction and guidance.

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
Submit your resume to apply!

Job Type: Full-time

Work Location: Multiple Locations