Quality Assurance Specialist

2 days ago

Bengaluru, Karnataka, India beBeeClinical Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Clinical Trials Quality Assurance Specialist

This role is responsible for ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management.

Job Description

As a Clinical Trials Quality Assurance Specialist, you will play a key role in leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study Key Risk Indicators (KRIs), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings.

You will work closely with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's specific needs, including identification of critical data & processes, definition of KRIs & Quality Thresholds Limits (QTLs), and centralized monitoring approach.

Key responsibilities include:

  • Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's specific needs.
  • Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
  • Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
  • RBQM Meetings: Lead facilitation of monthly RBQM meetings by supporting review of study data, documenting findings, action plans, and coordination of data cleaning activities to support study deliverables.
Required Skills and Qualifications

To be successful in this role, you will need:

  • Minimum Required:
    • Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
    • Minimum 5 years experience in clinical monitoring, clinical trial management, or equivalent.
    • Working knowledge of ICH GCP guidelines and the clinical development process.
  • Other Required:
    • Highly effective oral and written communication skills with the ability to communicate effectively with project team members.
    • Excellent organizational and time management skills.
    • Excellent written and spoken English, including strong grammar and scientific vocabulary skills.
    • Ability to work in a team or independently as required.
    • Strong understanding of RBQM principles and methodologies.
    • Demonstrated ability to learn how to extract pertinent information from protocols, electronic study data systems, clinical systems, dashboards, and to leverage these data to assess risk.
    • Proficiency in statistical analysis and data monitoring tools.
    • Detail-oriented with strong analytical and problem-solving skills.
    • Demonstrated experience with integrated risk planning & management.
    • Ability to mentor junior team members.
Benefits

As a Clinical Trials Quality Assurance Specialist, you will have the opportunity to work in a dynamic and growing industry, with opportunities for professional growth and development.

Additionally, you will be part of a collaborative and supportive team environment, with opportunities for career advancement and recognition.

Others

We are an equal opportunity employer and welcome applications from diverse candidates. If you are interested in this role, please submit your application with your resume and cover letter.

  • Quality Assurance Specialist

    4 days ago

    Bengaluru, Karnataka, India beBeeQuality Full time ₹ 9,00,000 - ₹ 12,00,000

    Job Title: Quality Assurance Specialist Job Description We are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring that our software products meet the highest standards of quality. Required Skills and Qualifications Functional, API testing, Mobile...

  • Quality Assurance Specialist

    2 days ago

    Bengaluru, Karnataka, India beBeeAutomation Full time ₹ 18,00,000 - ₹ 24,00,000

    Quality Assurance Specialist Job OpportunityJob Title: Quality Assurance SpecialistWe are seeking a skilled Quality Assurance Specialist to play a crucial role in ensuring our products meet the highest quality standards.About This RoleDesign and execute comprehensive testing strategies for security, API, and regression suites.Develop automation scripts and...

  • Quality Assurance Specialist

    1 day ago

    Bengaluru, Karnataka, India beBeeQuality Full time ₹ 60,00,000 - ₹ 1,20,00,000

    Quality Assurance SpecialistWe are seeking a skilled Quality Assurance Specialist to deliver high-quality software testing services. Key Responsibilities:Develop and execute test procedures in JIRA and Zephyr to ensure product requirements are met.Coordinate project deliverables, testing, and production support issues with cross-functional teams.Assess...

  • Quality Assurance Specialist

    5 days ago

    Bengaluru, Karnataka, India beBeeQuality Full time ₹ 15,00,000 - ₹ 25,00,000

    Job Title: Quality Assurance SpecialistJob DescriptionAs a Quality Assurance Specialist, you will play a pivotal role in ensuring the highest quality standards are met across the application lifecycle. You will be responsible for designing, developing, and executing test plans, test cases, and test scripts for web and mobile applications.You will work...

  • Quality Assurance Specialist

    4 days ago

    Bengaluru, Karnataka, India beBeeQuality Full time

    Job Title: Quality Assurance SpecialistAt our company, we are seeking a Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality assurance and regulatory compliance.About the Role:The primary responsibility of this role is to ensure that all products meet the required quality standards.The Quality Assurance...

  • Quality Assurance Specialist

    3 days ago

    Bengaluru, Karnataka, India beBeeTestAutomation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

    Job Role: Quality Assurance SpecialistAbout the JobWe are seeking a skilled Quality Assurance Specialist to join our team. The ideal candidate will have expertise in test automation, software quality assurance, and continuous integration.The successful candidate will be responsible for developing, maintaining, and executing automated test scripts using TOSCA...

  • Quality Assurance Specialist

    1 day ago

    Bengaluru, Karnataka, India beBeePerformance Full time ₹ 9,00,000 - ₹ 12,00,000

    Job Title: Quality Assurance SpecialistWe are seeking a skilled Quality Assurance Specialist to join our team. This is an exciting opportunity for individuals who want to ensure the highest quality of software products.Responsibilities:Design and execute test plans, cases, and scripts to identify defects in software applications.Analyze and report defects to...

  • Software Quality Assurance Specialist

    1 day ago

    Bengaluru, Karnataka, India beBeeQuality Full time ₹ 26,00,000 - ₹ 30,00,000

    Role Overview:Software Quality Assurance SpecialistWe are seeking an experienced software quality assurance specialist to ensure the quality of our software applications.

  • Quality Assurance Specialist

    20 hours ago

    Bengaluru, Karnataka, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000

    Job Title: Quality Assurance SpecialistA Quality Assurance Specialist is a critical role that involves the development and implementation of quality management systems to ensure compliance with international standards.The ideal candidate will have expertise in establishing policies, procedures, and processes to drive continuous improvement and enhance...

  • Quality Assurance Specialist

    4 days ago

    Bengaluru, Karnataka, India beBeeQualityAssurance Full time US$ 98,700 - US$ 1,22,500

    Job Title: Quality Assurance SpecialistThe role of a Quality Assurance Specialist is a challenging and rewarding opportunity to contribute to the development and maintenance of software automation test scripts.We are seeking a highly skilled and experienced professional who can help us ensure the quality of our products and systems. Key responsibilities...