Business Analyst Veeva CTMS / eTMF Work location : Remote Duration: Full Time * Bachelor's degree preferably in Computer Science, Information technology, Computer Engineering, or related IT ...
Business Analyst Veeva CTMS / eTMF Work location : Remote Duration: Full Time * Bachelor's degree preferably in Computer Science, Information technology, Computer Engineering, or related IT ...
... eTMF in a GxP-regulated pharmaceutical environment. 🔑 Key Skills Required: • Deep experience with Veeva Vault Clinical (CTMS & eTMF) • Siebel CTMS experience • Experience with CTMS ↔ eTMF ...
... eTMF in a GxP-regulated pharmaceutical environment. 🔑 Key Skills Required: • Deep experience with Veeva Vault Clinical (CTMS & eTMF) • Siebel CTMS experience • Experience with CTMS ↔ eTMF ...
Specialist, Clinical Trials
San Diego, CA · On-site
Ensures eTMF documents are maintained in an organized manner in accordance with CRO and/or NBI SOPs, policies and standards. Performs sponsor oversight eTMF QC or Inspection Readiness QC within the ...
Specialist, Clinical Trials
San Diego, CA · On-site
Ensures eTMF documents are maintained in an organized manner in accordance with CRO and/or NBI SOPs, policies and standards. Performs sponsor oversight eTMF QC or Inspection Readiness QC within the ...
Ensures eTMF documents are maintained in an organized manner in accordance with CRO and/or NBI SOPs, policies and standards. Performs sponsor oversight eTMF QC or Inspection Readiness QC within the ...
Ensures eTMF documents are maintained in an organized manner in accordance with CRO and/or NBI SOPs, policies and standards. Performs sponsor oversight eTMF QC or Inspection Readiness QC within the ...
Deep understanding of Veeva Vault applications such as Clinical Operations (eTMF, CTMS, Study Training, Study Startup). * Ensuring system configurations meet GxP compliance, audit, and regulatory ...
New
Deep understanding of Veeva Vault applications such as Clinical Operations (eTMF, CTMS, Study Training, Study Startup). * Ensuring system configurations meet GxP compliance, audit, and regulatory ...
New
Sr. Product Specialist
Foster City, CA · On-site
Knowledge on other Vault like Vault eTMF, Vault Promomats etc is good to have but not mandatory. Experience in Veeva SDK Code development ( Good to Have) Excellent communication kills Ability to work ...
Sr. Product Specialist
Foster City, CA · On-site
Knowledge on other Vault like Vault eTMF, Vault Promomats etc is good to have but not mandatory. Experience in Veeva SDK Code development ( Good to Have) Excellent communication kills Ability to work ...
Lead monthly eTMF meetings for internal CO Study Team * Manages the Clinical System, including managing user access, user training, and system releases * Act as lead Clinical System Admin (add ...
Lead monthly eTMF meetings for internal CO Study Team * Manages the Clinical System, including managing user access, user training, and system releases * Act as lead Clinical System Admin (add ...
Lead monthly eTMF meetings for internal CO Study Team * Manages the Clinical System, including managing user access, user training, and system releases * Act as lead Clinical System Admin (add ...
Lead monthly eTMF meetings for internal CO Study Team * Manages the Clinical System, including managing user access, user training, and system releases * Act as lead Clinical System Admin (add ...
Clinical Trial Assistant
Foster City, CA · On-site
$75K - $90K/yr
Maintain, organize and QC Trial Master Files (TMF/eTMF) to ensure inspection readiness at all times * Assist with study start-up activities, including collection and tracking of regulatory documents ...
Clinical Trial Assistant
Foster City, CA · On-site
$75K - $90K/yr
Maintain, organize and QC Trial Master Files (TMF/eTMF) to ensure inspection readiness at all times * Assist with study start-up activities, including collection and tracking of regulatory documents ...
Clinical Trial Assistant
Foster City, CA · On-site
Maintain, organize and QC Trial Master Files (TMF/eTMF) to ensure inspection readiness at all times * Assist with study start-up activities, including collection and tracking of regulatory documents ...
Clinical Trial Assistant
Foster City, CA · On-site
Maintain, organize and QC Trial Master Files (TMF/eTMF) to ensure inspection readiness at all times * Assist with study start-up activities, including collection and tracking of regulatory documents ...
Sr. Product Specialist
Foster City, CA · On-site
Knowledge on other Vault like Vault eTMF, Vault Promomats etc is good to have but not mandatory. Experience in Veeva SDK Code development ( Good to Have) Excellent communication skills Ability to ...
Sr. Product Specialist
Foster City, CA · On-site
Knowledge on other Vault like Vault eTMF, Vault Promomats etc is good to have but not mandatory. Experience in Veeva SDK Code development ( Good to Have) Excellent communication skills Ability to ...
In-house Sr Clinical Research Associate
San Diego, CA · On-site
$60 - $75/hr
Review and maintain the electronic Trial Master File (eTMF) in compliance with SOPs, GCP, and ICH guidelines * Support study start-up and ongoing trial activities, including regulatory documentation ...
In-house Sr Clinical Research Associate
San Diego, CA · On-site
$60 - $75/hr
Review and maintain the electronic Trial Master File (eTMF) in compliance with SOPs, GCP, and ICH guidelines * Support study start-up and ongoing trial activities, including regulatory documentation ...
Manage projects such as eTMF governance, AI and automation initiatives, CDx workflows, SOP development, inspection readiness, clinical systems implementations, and process improvement programs.
New
Manage projects such as eTMF governance, AI and automation initiatives, CDx workflows, SOP development, inspection readiness, clinical systems implementations, and process improvement programs.
New
Salesforce Solution Architect and Lead Engineer for CTMS
San Jose, CA · On-site
$81.75 - $101.25/hr
Understanding of CTMS, eTMF (Electronic Trial Master File), and EDC (Electronic Data Capture) . * Working knowledge of 21 CFR Part 11 , GCP , and HIPAA regulations. * Experience integrating ...
Quick apply
Salesforce Solution Architect and Lead Engineer for CTMS
San Jose, CA · On-site
$81.75 - $101.25/hr
Understanding of CTMS, eTMF (Electronic Trial Master File), and EDC (Electronic Data Capture) . * Working knowledge of 21 CFR Part 11 , GCP , and HIPAA regulations. * Experience integrating ...
Clinical Trial Assistant
San Francisco, CA · Hybrid
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Clinical Trial Assistant
San Francisco, CA · Hybrid
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Clinical Trial Assistant
San Francisco, CA · Hybrid
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Clinical Trial Assistant
San Francisco, CA · Hybrid
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Clinical Trial Assistant
San Francisco, CA · On-site
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Clinical Trial Assistant
San Francisco, CA · On-site
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Clinical Trial Assistant
San Francisco, CA · On-site
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Clinical Trial Assistant
San Francisco, CA · On-site
$56K - $70K/yr
Lead the setup of electronic Trial Master File (eTMF) system and clinical trial management (CTMS). Ensure information is updated during the study per ICH/GCP and sponsor SOP's * Create and maintain ...
Solution Sales Specialist - Study Experience (West Coast Biotech)
Davis, CA · On-site
$135K - $160K/yr
I bring a deep, hands-on understanding of Clinical Operations workflows, CTMS, eTMF, and Site Payments. * Collaborate with Product, Marketing, and Strategy teams to channel market intelligence ...
Solution Sales Specialist - Study Experience (West Coast Biotech)
Davis, CA · On-site
$135K - $160K/yr
I bring a deep, hands-on understanding of Clinical Operations workflows, CTMS, eTMF, and Site Payments. * Collaborate with Product, Marketing, and Strategy teams to channel market intelligence ...
Solution Sales Specialist - Study Experience (West Coast Biotech)
Davis, CA · On-site
$135K - $160K/yr
I bring a deep, hands-on understanding of Clinical Operations workflows, CTMS, eTMF, and Site Payments. * Collaborate with Product, Marketing, and Strategy teams to channel market intelligence ...
Solution Sales Specialist - Study Experience (West Coast Biotech)
Davis, CA · On-site
$135K - $160K/yr
I bring a deep, hands-on understanding of Clinical Operations workflows, CTMS, eTMF, and Site Payments. * Collaborate with Product, Marketing, and Strategy teams to channel market intelligence ...
Etmf information
What is an eTMF?
An eTMF (electronic Trial Master File) job involves managing and maintaining digital documentation related to clinical trials. Professionals in this role ensure regulatory compliance, organize essential trial documents, and support inspection readiness. They may use eTMF systems to track, classify, and archive trial-related files. Strong attention to detail and knowledge of clinical research regulations are essential.
What are the typical daily responsibilities of an eTMF specialist?
As an eTMF Specialist, your daily responsibilities include managing, organizing, and maintaining essential clinical trial documents within the electronic Trial Master File system. You will monitor document completeness, track filing timelines, and ensure regulatory compliance, often collaborating with clinical, regulatory, and quality assurance teams. Regular audits, resolving document discrepancies, and training other team members on eTMF processes are also common tasks. The role requires staying up to date with changing regulatory requirements and maintaining clear communication with multiple stakeholders to support successful clinical trial operations.
What are the key skills and qualifications needed to thrive in the eTMF position, and why are they important?
To thrive as an eTMF (electronic Trial Master File) Specialist, you need a strong understanding of clinical trial documentation, regulatory requirements, and document management best practices, often supported by a degree in life sciences or a related field. Familiarity with eTMF systems such as Veeva Vault or Medidata, as well as relevant certifications like the DIA TMF Certificate, is highly beneficial. Attention to detail, excellent organizational skills, and effective cross-functional communication make candidates stand out in this role. These competencies are crucial for ensuring that clinical trial documentation is complete, inspection-ready, and compliant with industry regulations.
What are the most commonly searched types of Etmf jobs in California?
The most popular types of Etmf jobs in California are:
What are popular job titles related to Etmf jobs in California?
For Etmf jobs in California, the most frequently searched job titles are:
What job categories do people searching Etmf jobs in California look for?
The top searched job categories for Etmf jobs in California are:
Full-time
Posted 5 days ago
Job description
Our client seeks an Business Analyst Veeva CTMS / eTMF for a Full Time project in Remote.Below is the detailed requirement
Job Title: Business Analyst Veeva CTMS / eTMF
Work location : Remote
Duration: Full Time
Job Description:
Skills & Experience
Business Analysis Leadership/Execution & Veeva Vault Clinical Expertise
Migration and Transformation Leadership -- Lead/contribute to large-scale system migration legacy CTMS (Siebel) to Veeva Vault Clinical and related transformation efforts; Drive/participate in migration planning, including cutover strategy, data validation approach, reconciliation methods, rollback planning, communications, change management, and archiving strategy; Help to coordinate technical and business readiness across all stakeholder groups.
Validation, Compliance, Release and Environment Management -- Provide oversight and coordination for Veeva Vault Clinical releases across non-production and production environments; As needed, partner with QA, Val, and IT to ensure delivery aligns with GxP and validation expectations; Drive release impact assessments, cross-functional readiness reviews, and deployment sequencing in partnership with IT, QA, Val and development teams; Ensure appropriate governance and usage of development, test, and UAT environments to support parallel workstreams and testing cycles; Act as a single point of orchestration for release- and environment-related dependencies, risks, and conflicts; Ensure releases are executed in a compliant, predictable, and business-aligned manner; Provide oversight and contribution to validation approaches, UAT strategy, and release documentation.
Executive Communication and Clinical Systems Leadership Enablement -- Operate as a trusted advisor and analyst for Clinical Systems LT; Lead routine internal Clinical Systems Meeting to ensure internal alignment on technical and operational decisions/risks/updates on the Vault Clinical program; Deliver concise, executive-ready communication on progress, risks, trade-offs, and decisions required; Influence with minimal oversight to gain alignment and drive outcomes across senior stakeholder groups.
Preferred / Nice-to-haves -- Experience with system integrations (e.g., CTMS ↔ eTMF/EDC/Data Lakes & repositories); Experience working with Siebel (CTMS), working with Veeva Managed Services or vendor escalations. Familiarity with Agile or DevOps methodologies; Knowledge of clinical metrics and reporting tools; Experience with system integrations, APIs, middleware, and data platforms. Siebel CTMS experience, particularly in migration or decommissioning efforts; Experience with Veeva Managed Services or external vendors. Exposure to operational metrics, reporting, or analytics in a clinical systems setting.
Job Title: Business Analyst Veeva CTMS / eTMF
Work location : Remote
Duration: Full Time
Job Description:
- Bachelor's degree preferably in Computer Science, Information technology, Computer Engineering, or related IT discipline or equivalent experience with 12+ Minimum Experience
Skills & Experience
- Business Analyst with 10 years of experience delivering/leading regulated enterprise/clinical systems initiatives
- Hands-on experience with Veeva Vault Clinical (CTMS and eTMF); Strong understanding of clinical trial operations and clinical systems workflows
- Strong technical fluency to partner effectively with internal and external teams in Business, IT, Data, Infrastructure, and QA
- Demonstrated experience overseeing release and environment management in a GxP-regulated environment
- Proven ability to lead complex, cross-functional initiatives and drive clarity from ambiguity
- Excellent executive communication, documentation, and stakeholder management skills
- Bachelor's degree in Life Sciences, Information Systems, or related field
Business Analysis Leadership/Execution & Veeva Vault Clinical Expertise
- Lead complex, cross-functional initiatives related to Veeva Vault Clinical (CTMS/eTMF), including implementation, optimization efforts, migrations, and strategic enhancements
- Convert ambiguity into clear problem statements, scope, success criteria, execution plans, timelines, risks, and decision points; Proactively manage dependencies, trade-offs, and risks
- Elevate decisions with clear recommendations to Clinical Systems LT; Serve as a SME for Veeva Vault Clinical (CTMS/eTMF), advising on configuration implications, functional capabilities, and downstream system impacts; Partner with development and support teams on complex or systemic issues, contributing to root-cause analysis and long-term solutions
- Participate in enhancement definition, prioritization, solution design, and validation strategy; Collaborate closely with integration and data teams on end-to-end clinical system workflows
- Review key technical and functional documentation, including business and system requirements, design specifications, release notes, validation plans, and SOPs
- Act as a translator between technical and business audiences, validating that documentation clearly reflects scope, assumptions, risks, and downstream impacts
- Ensure documentation is complete, accurate, and aligned with intended business outcomes, system behavior, and regulatory expectations
- Partner with CS Leads, QA, Val, and IT to ensure documentation supports validation, inspection readiness, and audit traceability
Migration and Transformation Leadership -- Lead/contribute to large-scale system migration legacy CTMS (Siebel) to Veeva Vault Clinical and related transformation efforts; Drive/participate in migration planning, including cutover strategy, data validation approach, reconciliation methods, rollback planning, communications, change management, and archiving strategy; Help to coordinate technical and business readiness across all stakeholder groups.
Validation, Compliance, Release and Environment Management -- Provide oversight and coordination for Veeva Vault Clinical releases across non-production and production environments; As needed, partner with QA, Val, and IT to ensure delivery aligns with GxP and validation expectations; Drive release impact assessments, cross-functional readiness reviews, and deployment sequencing in partnership with IT, QA, Val and development teams; Ensure appropriate governance and usage of development, test, and UAT environments to support parallel workstreams and testing cycles; Act as a single point of orchestration for release- and environment-related dependencies, risks, and conflicts; Ensure releases are executed in a compliant, predictable, and business-aligned manner; Provide oversight and contribution to validation approaches, UAT strategy, and release documentation.
Executive Communication and Clinical Systems Leadership Enablement -- Operate as a trusted advisor and analyst for Clinical Systems LT; Lead routine internal Clinical Systems Meeting to ensure internal alignment on technical and operational decisions/risks/updates on the Vault Clinical program; Deliver concise, executive-ready communication on progress, risks, trade-offs, and decisions required; Influence with minimal oversight to gain alignment and drive outcomes across senior stakeholder groups.
Preferred / Nice-to-haves -- Experience with system integrations (e.g., CTMS ↔ eTMF/EDC/Data Lakes & repositories); Experience working with Siebel (CTMS), working with Veeva Managed Services or vendor escalations. Familiarity with Agile or DevOps methodologies; Knowledge of clinical metrics and reporting tools; Experience with system integrations, APIs, middleware, and data platforms. Siebel CTMS experience, particularly in migration or decommissioning efforts; Experience with Veeva Managed Services or external vendors. Exposure to operational metrics, reporting, or analytics in a clinical systems setting.
About Lorven technologies
Sourced by ZipRecruiter
Lorven Technologies, headquartered in Plainsboro, New Jersey, United States, is a reputable company in the technology industry, specializing in providing effective IT solutions and consulting services. The company's official website, lorventech.com, offers comprehensive insights into its offerings which include but are not limited to software development, IT consulting, project management, and business analysis. Since its inception, Lorven Technologies has been committed to ensuring efficiency and reliability in delivering IT services to its global clientele, establishing itself as a trusted name in the industry.
Industry
It services
Company size
51 - 200 Employees
Headquarters location
Plainsboro, NJ, US
Year founded
2001