Insight Global
Job Description
We are seeking a skilled and experienced Business Systems Compliance -Senior Analyst to enhance and verify the compliance and computer systems validation (CSV) capabilities across systems managed by Global Development Information Management (G-DIM). This individual will be responsible for assessing the compliance status of R&D computerized systems, developing of continuous improvement / CAPA plans, training and awareness sessions on inspection readiness and acting as CSV advisor on new implementations, changes and incidents. Lead and execute CSV activities for R&D regulated computerized systems, such as EDC, CTMS, eTMF, and other clinical platforms. Develop and review validation documentation: URS, FS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrix, and Validation Plans/Reports. Ensure compliance with applicable regulations (e.g., FDA 21 CFR Part 11, EU Annex 11, ICH E6(R3)). Collaborate with cross-functional teams including QA, IT, Clinical Operations, and vendors. Conduct gap assessments, periodic reviews, and remediation planning for R&D computerized systems. Provide expert advice on data integrity, system lifecycle management, and change control. Train internal teams and clients on CSV best practices and regulatory expectations.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .
Skills and Requirements
Bachelors or Masters degree in Life Sciences, Computer Science, Engineering, or related field.
Minimum 5 years of experience in GxP CSV, with a strong focus on R&D systems.
In-depth knowledge of clinical trial and regulatory processes and associated computerized systems.
Proven experience with validation of SaaS/cloud-based platforms.
Strong understanding of regulatory frameworks (FDA, EMA, MHRA, ICH).
Excellent communication, documentation, and project management skills.
Ability to work independently and manage multiple projects simultaneously.
Experience working with one of these clinical systems (e.g., EDC, CTMS, eTMF) and regulatory platforms (e.g., RIM, eCTD). Experience with vendor qualification and third-party audits.
Familiarity with Agile and SDLC methodologies.
Exposure to technologies such as NLP, LLMs, or workflow automation in life sciences. null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.
We are seeking a skilled and experienced Business Systems Compliance -Senior Analyst to enhance and verify the compliance and computer systems validation (CSV) capabilities across systems managed by Global Development Information Management (G-DIM). This individual will be responsible for assessing the compliance status of R&D computerized systems, developing of continuous improvement / CAPA plans, training and awareness sessions on inspection readiness and acting as CSV advisor on new implementations, changes and incidents. Lead and execute CSV activities for R&D regulated computerized systems, such as EDC, CTMS, eTMF, and other clinical platforms. Develop and review validation documentation: URS, FS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrix, and Validation Plans/Reports. Ensure compliance with applicable regulations (e.g., FDA 21 CFR Part 11, EU Annex 11, ICH E6(R3)). Collaborate with cross-functional teams including QA, IT, Clinical Operations, and vendors. Conduct gap assessments, periodic reviews, and remediation planning for R&D computerized systems. Provide expert advice on data integrity, system lifecycle management, and change control. Train internal teams and clients on CSV best practices and regulatory expectations.
We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .
To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .
Skills and Requirements
Bachelors or Masters degree in Life Sciences, Computer Science, Engineering, or related field.
Minimum 5 years of experience in GxP CSV, with a strong focus on R&D systems.
In-depth knowledge of clinical trial and regulatory processes and associated computerized systems.
Proven experience with validation of SaaS/cloud-based platforms.
Strong understanding of regulatory frameworks (FDA, EMA, MHRA, ICH).
Excellent communication, documentation, and project management skills.
Ability to work independently and manage multiple projects simultaneously.
Experience working with one of these clinical systems (e.g., EDC, CTMS, eTMF) and regulatory platforms (e.g., RIM, eCTD). Experience with vendor qualification and third-party audits.
Familiarity with Agile and SDLC methodologies.
Exposure to technologies such as NLP, LLMs, or workflow automation in life sciences. null
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.