IRT Test Analyst - Remote Position

We need to output HTML fragment with sections: headings

for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to include only sections that have real content. The posting includes description of duties, responsibilities, qualifications, required skills, required experience. No explicit Benefits, Pay, Schedule. So we should not create those sections. We need to use

for section headings. Use

• for any list of duties/requirements/benefits, and

  for prose. We need to preserve all substantive information, not invent or summarize away detail. Remove boilerplate etc. The posting includes: "The IRT Test Analyst will use software test methodologies to write and execute test plans and use cases related to the functionality of the IRT System and project specific configuration and custom coding. The Test Analyst will be responsible to document and track system or configuration errors through resolution." Then "Essential Duties And Responsibilities" heading (but we shouldn't repeat job title as heading). We can treat "Essential Duties And Responsibilities" as a section heading? The instruction: use

  for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can map "Essential Duties And Responsibilities" to Responsibilities. So we can have

  Responsibilities

  . Then list duties as
  • ... each bullet. Then "Qualifications" heading: we can have

    Qualifications

    . Then list required skills and required experience maybe as sublists? Could combine into one list? But we need to preserve detail. Could have two subsections? Not required. Could have

    Required Skills

    and

    Required Experience

    but those aren't in the allowed list; but we could still use

    for any section heading? The instruction says use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It implies those are examples but we can use other headings? Probably better to stick to those categories. So we can put skills under Skills heading, experience under Requirements or Qualifications? The posting has "Qualifications" then "Required Skills:" and "Required Experience:". So we could have

    Skills

    for required skills, and

    Requirements

    for required experience (or qualifications). But we also have a Qualifications section overall. Might be redundant. Let's think: The posting includes a "Qualifications" heading then subheadings Required Skills and Required Experience. We could map: -

    Responsibilities

    (list duties) -

    Skills

    (list required skills) -

    Requirements

    (list required experience) We could also have

    Qualifications

    but that would duplicate. Better to follow the examples: Responsibilities, Skills, Requirements. No About the role, Benefits, Pay, Schedule. We need to preserve all substantive information: The duties list includes many bullet points. Let's extract them from the text. Original text after "Essential Duties And Responsibilities": "The IRT Test Analyst is responsible for the testing of project specific study configurations and protocol amendments within the IRT System and versioned releases of the IRT Core System. The IRT Test Analyst will be expected to serve as primary subject matter expert (SME) for software testing. Write Test Plans in accordance with GAMP 5 and software methodologies. Create use and/or test cases based off the requirements specifications and test plan. Execute approved test cases. Maintain issues log of errors noted during test execution. Create testing summary at the end of test execution, and work with IRT Project Manager on resolution plan. Communicate status of testing to the project team. Maintain Testing Documentation. Review and provide input in requirement specifications, high focus on risk to patient safety and data integrity. Provide test case and testing documentation peer reviews. Assist IRT Project Manager with the development of testing timelines. Assist IRT Project Manager with the set-up of Client Acceptance Testing. Ensure timely delivery of all project related deliverables, escalate any risk to the timelines to the IRT Project Manager. Assist in the maintenance of the IRT Project File. Understand and adhere to Standard Operating Procedures (SOP) and Work Instructions (WI)Contribute SME knowledge as applicable to create/update Standard Operating Procedures (SOP)Prepare for and participate in internal/external audits and regulatory investigations. Participate in Quality Investigations. Initiate Quality Events as defined in Standard Operating Procedures." We need to split into sensible bullet points. Each sentence could be a bullet. Ensure we don't lose any detail. Let's list: - Responsible for testing of project specific study configurations and protocol amendments within the IRT System and versioned releases of the IRT Core System. - Expected to serve as primary subject matter expert (SME) for software testing. - Write Test Plans in accordance with GAMP 5 and software methodologies. - Create use and/or test cases based off the requirements specifications and test plan. - Execute approved test cases. - Maintain issues log of errors noted during test execution. - Create testing summary at the end of test execution, and work with IRT Project Manager on resolution plan. - Communicate status of testing to the project team. - Maintain Testing Documentation. - Review and provide input in requirement specifications, with high focus on risk to patient safety and data integrity. - Provide test case and testing documentation peer reviews. - Assist IRT Project Manager with the development of testing timelines. - Assist IRT Project Manager with the set-up of Client Acceptance Testing. - Ensure timely delivery of all project related deliverables, escalate any risk to the timelines to the IRT Project Manager. - Assist in the maintenance of the IRT Project File. - Understand and adhere to Standard Operating Procedures (SOP) and Work Instructions (WI). - Contribute SME knowledge as applicable to create/update Standard Operating Procedures (SOP). - Prepare for and participate in internal/external audits and regulatory investigations. - Participate in Quality Investigations. - Initiate Quality Events as defined in Standard Operating Procedures. Now Required Skills: "Experience with and demonstrated understanding of computer systems and software application implementation including knowledge of software development life cycle. Strong communication skills, job requires communication with internal stakeholders and vendors. Basic knowledge of SQL, XML Web services, sFTP and SAS. Working knowledge of personal computers and Microsoft Office Products, including Word, Project, Excel and Power Point." We can bullet each: - Experience with and demonstrated understanding of computer systems and software application implementation including knowledge of software development life cycle. - Strong communication skills; job requires communication with internal stakeholders and vendors. - Basic knowledge of SQL, XML Web services, sFTP and SAS. - Working knowledge of personal computers and Microsoft Office Products, including Word, Project, Excel and Power Point. Required Experience: "Bachelor’s degree or equivalent work experience. 2-3 years’ experience in a similar quality management or testing role. Must have 3+ years’ experience working at a CRO or pharmaceutical company on clinical research and development projects with experience using IRT, EDC, or ePRO Systems. Knowledge of clinical research industry, standard practices and GHC, ICH/GCP guidelines and FDA Regulations. Knowledge and understanding of regulations associated with clinical trial data handling, including HIPAA, GDPR and 21 CFR Part 11." Bullet: - Bachelor’s degree or equivalent work experience. - 2-3 years’ experience in a similar quality management or testing role. - Must have 3+ years’ experience working at a CRO or pharmaceutical company on clinical research and development projects with experience using IRT, EDC, or ePRO Systems. - Knowledge of clinical research industry, standard practices and GHC, ICH/GCP guidelines and FDA Regulations. - Knowledge and understanding of regulations associated with clinical trial data handling, including HIPAA, GDPR and 21 CFR Part 11. Now we need to output HTML fragment with

    Responsibilities

    ...
    ,

    Skills

    ...
    ,

    Requirements

    ...
    . Use

    for prose if any. There's no prose besides maybe an introductory sentence? The first sentence before "Essential Duties And Responsibilities": "The IRT Test Analyst will use software test methodologies to write and execute test plans and use cases related to the functionality of the IRT System and project specific configuration and custom coding. The Test Analyst will be responsible to document and track system or configuration errors through resolution." That could be considered an "About the role" summary. We could include an

    About the role

    with those two sentences in

    . The instruction says use

    for section headings (e.g. About the role, Responsibilities...). So we can include About the role. That would be good to capture that intro. Then Responsibilities, Skills, Requirements. Thus sections: About the role, Responsibilities, Skills, Requirements. We must not repeat job title as heading. That's fine. Now produce HTML:

    About the role

    The IRT Test Analyst will use software test methodologies to write and execute test plans and use cases related to the functionality of the IRT System and project specific configuration and custom coding. The Test Analyst will be responsible to document and track system or configuration errors through resolution.

    Responsibilities

    • Responsible for testing of project specific study configurations and protocol amendments within the IRT System and versioned releases of the IRT Core System.
    • Expected to serve as primary subject matter expert (SME) for software testing.
    • Write Test Plans in accordance with GAMP 5 and software methodologies.
    • Create use and/or test cases based off the requirements specifications and test plan.
    • Execute approved test cases.
    • Maintain issues log of errors noted during test execution.
    • Create testing summary at the end of test execution, and work with IRT Project Manager on resolution plan.
    • Communicate status of testing to the project team.
    • Maintain Testing Documentation.
    • Review and provide input in requirement specifications, with high focus on risk to patient safety and data integrity.
    • Provide test case and testing documentation peer reviews.
    • Assist IRT Project Manager with the development of testing timelines.
    • Assist IRT Project Manager with the set-up of Client Acceptance Testing.
    • Ensure timely delivery of all project related deliverables, escalate any risk to the timelines to the IRT Project Manager.
    • Assist in the maintenance of the IRT Project File.
    • Understand and adhere to Standard Operating Procedures (SOP) and Work Instructions (WI).
    • Contribute SME knowledge as applicable to create/update Standard Operating Procedures (SOP).
    • Prepare for and participate in internal/external audits and regulatory investigations.
    • Participate in Quality Investigations.
    • Initiate Quality Events as defined in Standard Operating Procedures.

    Skills

    • Experience with and demonstrated understanding of computer systems and software application implementation including knowledge of software development life cycle.
    • Strong communication skills; job requires communication with internal stakeholders and vendors.
    • Basic knowledge of SQL, XML Web services, sFTP and SAS.
    • Working knowledge of personal computers and Microsoft Office Products, including Word, Project, Excel and Power Point.

    Requirements

    • Bachelor’s degree or equivalent work experience.
    • 2-3 years’ experience in a similar quality management or testing role.
    • Must have 3+ years’ experience working