Merck KGaA

Clinical Software Validation Specialist

Posted On

April 8, 2024

Location

Bangalore, Karnataka

Experience Level

D - Professional (4-9 years)

Job Type

full-time

Apply By

Jan. 28, 2025

Job Description

Clinical Software Validation Specialist: This critical role focuses on ensuring the integrity and compliance of software libraries, such as R and Python, which are essential for the analysis of clinical trial data. The successful candidate will be instrumental in establishing and managing a robust software validation and qualification framework that meets and exceeds the standards set by global health authorities in compliance with Good Practice (GxP) regulations, for submissions and exploratory purposes. Software Libraries Management: take ownership of the software libraries including researching and evaluating new packages, selection, prioritization, managing updates and versions, and ensuring compatibility with existing workflows.Validation Framework: develop and maintain a comprehensive validation framework for software libraries used in clinical data analysis, ensuring compliance with GxP and health authority guidelines.Qualification Process: lead the qualification of R, Python, and other analytical software libraries, including the creation of validation plans, execution of validation protocols, and preparation of validation reports to meet regulatory and quality standardsCollaboration and Support: liaise with IT, clinical data scientists, statistical programmers biostatisticians and regulatory teams to ensure that the software validation processes align with both internal standards and external regulatory expectations. Provide technical expertise and act as a subject matter expert, assisting colleagues in troubleshooting Continuous Improvement: stay abreast of regulatory guidance from health authorities such as the FDA, EMA, and other global entities regarding the use of software, including AI/ML methods, in clinical research. Identify opportunities for process improvement, recommend enhancements, and implement best practices.Functional requirements: collaborate with statistical programmer, software developers, data scientists and biostatisticians to understand the functional requirements and intended use of software libraries in the context of clinical trialsRisk assessment process: develop and maintain a framework of risk assessment for software libraries and associated processes, to identify potential compliance risks and develop risk mitigation strategies.Support users: provide GxP compliance training and support to cross-functional teams to ensure a consistent understanding and approach to software qualification and validation.Process Automation: work on opportunities to automate the process for package validation and qualifications, including running tests and ensuring the integrity and functionality of the packages.Documentation: manage documentation and SOPs related to software library qualification and validation, ensuring traceability, and audit readiness. Compliance: ensure compliance with relevant regulations, standards, audits and guidelines in the organization and in the pharmaceutical industry. Promote internal concepts of validation awareness and accountability and serve as a focal point for any audits of software libraries Who you are:B.Sc (or higher) in Computer Science, Statistics, Data Science, Life Sciences Bioinformatics or equivalent industry experienceMinimum of 5 years of experience in a GxP regulated environment, with a strong focus on software validation. Advantage for pharmaceutical or life sciences environment.Proven track record of developing and executing software validation plans in a regulated environment.In depth understanding of GxP regulations and guidelines particularly as they relate to software validation in clinical trialsFamiliarity with clinical trial processes and data management standards is a plusExperience with R, Python, or similar statistical programming languages and software Experience working with and contributing to software communities, participation in online forums and collaborative platforms.Competencies:Attention to details and quality orientation to ensure accuracy, reliability and delivering high-quality solutions adhering to standards and guidelinesGood communication and collaboration skills to effectively interact with multidisciplinary teams in a cross-functional, global team environmentExcellent analytical and problem-solving skills with the ability to troubleshoot and debug software related issuesContinuous Learning: a passion for staying updated with the latest advancements in data science, R packages and regulatory requirements within the pharmaceutical industry. Actively seeking opportunities for new tools, methodologies and techniques We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, colour, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

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