ERT

Director, eCOA Service Delivery Quality Assurance

US-PA-Pittsburgh
Shift
Monday-Friday
Type
Regular Full-Time

Overview

ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that our customers can move ahead with confidence. With more than 45 years of clinical and therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising standards.

Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement, and measure the efficacy of new clinical treatments while ensuring patient safety. Over the past four years, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, Biotechs, and CROs have relied on ERT solutions in 9,500+ studies spanning three million patients to date. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly – and with confidence. For more information, go to ert.com or follow us on LinkedIn, Twitter, and Facebook.

 

We are currently seeking a Director, eCOA Service Delivery Quality Assurance in our Pittsburgh office. 

Responsibilities

1. Development (in tandem with Director, eCOA Service Delivery) and execution of strategic plans within eCOA Service Delivery Quality Assurance (QA – software and reports validation) to drive quality, process efficiencies and tool/automation efficiencies.

 

2. Establish and implement process and technology standards for all eCOA projects to ensure quality and timeliness for all deliverables (Data Capture for mobile and web, Reports, Notifications, Integrations, Translations, and Change Control).

 

3. Management of strategic service and technology business partnerships including:

    • Offshore Quality Assurance/Validation resources

4. Working closely with the Operational Readiness Office, ensure effective Operational Launch of new and updated platforms and products to ensure key launch strategies are met effectively, on-time and within budget.  

    • Development of Operational Readiness plans
    • Resource planning & project management duties

 

OTHER DUTIES AND RESPONSIBILITIES:

  1. Build departmental strategies aligned to support Corporate Goals and position tactical plans to ensure delivery excellence.
  2. Develop, Maintain & Report Key Performance Indicators within department and with technology and service partners to ensure Quality, Timeliness and Productivity goals are met.
  3. Cross-Functional platform & process awareness to ensure ‘best practice’ One ERT approach where applicable.
  4. Ability to operate as a leader outside of direct functions to drive required mentoring, development and support activities within the organization.
  5. Create or direct development of Standard Operating Procedures and Standard Work Instructions.

 

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

EDUCATION:

  • Bachelor’s Degree in Information Technology, Business Management or related field required.
  • Post Graduate Degree in Business Management or Information Systems preferred.
  • Equivalent combination of education and experience.

 

EXPERIENCE & SKILLS REQUIRED:

  • Minimum 10 years of software validation experience, preferably in a regulated environment.
  • Minimum 3 years QA in commercial, enterprise software
  • Minimum 2 years of software validation for mobile applications
  • Adept at leading, organizing and managing large cohesive teams across global locations
  • Proven ‘Best Practice’ process experience with focus on driving efficiency in Productivity, Quality and Timeliness.
  • Knowledgeable on current software industry software quality engineering techniques
  • Minimum of 2 years financial experience managing budgets at department and project level.
  • Strong Hardware, Software and Platform technical knowledge.
  • Extensive experience with RCA (root cause analysis) and CAPA (corrective action/preventative action) to drive continuous improvement intra-departmentally and cross-functionally.
  • Experience with a variety of Software Development Life Cycles including Agile
  • Proven leadership capability.
  • Excellent organizational, analytical and communication skills.

 

HIGHLY PREFERRED EXPERIENCE & SKILLS:

  • Global Clinical Operations experience with focus on the clinical trial phases and associated lifecycles.
  • Strong understanding and working knowledge of FDA and international regulations and guidelines:
    • 21 CFR (specifically Parts 11, 820, 821)
    • Annex 11
    • ICH/GCP
    • HIPAA
  • Guidance for Industry Electronic Source Data in Clinical Investigations
  • Guidance for Industry Patient-Reported Outcome Measures:  Use in Medical Product Development to Support Labeling Claims
  • Guidance for Industry Mobile Medical Applications
  • Computerized Systems Used in Clinical Trials

 

 

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.

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