Business Analyst Veeva Vault Clinical (CTMS/eTMF) Work location : Remote Duration: Full Time * Bachelor's degree preferably in Computer Science, Information technology, Computer Engineering, or ...
Business Analyst Veeva Vault Clinical (CTMS/eTMF) Work location : Remote Duration: Full Time * Bachelor's degree preferably in Computer Science, Information technology, Computer Engineering, or ...
Serve as a CTMS and eTMF Subject Matter Expert (SME), providing end-user support and ... Remote employees work entirely from home except for attending Company sponsored events/ meetings.
Serve as a CTMS and eTMF Subject Matter Expert (SME), providing end-user support and ... Remote employees work entirely from home except for attending Company sponsored events/ meetings.
Remote (EST Hours - USA) Long Term Contract We are seeking a skilled Veeva Safety Consultant with ... Experience with Veeva Vault QMS, RIM, or eTMF . * Familiarity with GxP compliance and validation ...
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Remote (EST Hours - USA) Long Term Contract We are seeking a skilled Veeva Safety Consultant with ... Experience with Veeva Vault QMS, RIM, or eTMF . * Familiarity with GxP compliance and validation ...
Veeva Project Lead
Foster City, CA · On-site +1
Remote Duration: Full Time * Bachelor's degree preferably in Computer Science, Information ... CTMS and eTMF systems for configuration, user support, and compliance management. * 4+ years ...
Veeva Project Lead
Foster City, CA · On-site +1
Remote Duration: Full Time * Bachelor's degree preferably in Computer Science, Information ... CTMS and eTMF systems for configuration, user support, and compliance management. * 4+ years ...
Clinical Operations Manager
Pennington, NJ · On-site +1
... Remote monitoring support and follow-up o Query and action item tracking o TMF/eTMF filing support and completeness checks * Review IHCRA outputs for quality, timeliness, and compliance * Provide ...
Clinical Operations Manager
Pennington, NJ · On-site +1
... Remote monitoring support and follow-up o Query and action item tracking o TMF/eTMF filing support and completeness checks * Review IHCRA outputs for quality, timeliness, and compliance * Provide ...
Clinical Project Associate - Remote US
Concord, NC · On-site +1
$31.25 - $42.50/hr
This position is remote based in the US; relocation assistance and visa sponsorship are not ... You will set-up, document collection/upload of files to the TMF/eTMF * You will perform initial ...
Clinical Project Associate - Remote US
Concord, NC · On-site +1
$31.25 - $42.50/hr
This position is remote based in the US; relocation assistance and visa sponsorship are not ... You will set-up, document collection/upload of files to the TMF/eTMF * You will perform initial ...
Clinical Research Assistant
Silver Spring, MD · Remote
$45K - $55K/hr
This is a remote position. Position Overview We are seeking a motivated and detail-oriented ... Experience using Electronic Data Capture (EDC), CTMS, or eTMF systems. * Knowledge of clinical ...
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Clinical Research Assistant
Silver Spring, MD · Remote
$45K - $55K/hr
This is a remote position. Position Overview We are seeking a motivated and detail-oriented ... Experience using Electronic Data Capture (EDC), CTMS, or eTMF systems. * Knowledge of clinical ...
The role will be based in Palo Alto, CA or be remote and reports to the Director, Clinical ... Assists CRAs in ensuring eTMF completeness, eTMF audit findings and resolutions. * Manages and/or ...
New
The role will be based in Palo Alto, CA or be remote and reports to the Director, Clinical ... Assists CRAs in ensuring eTMF completeness, eTMF audit findings and resolutions. * Manages and/or ...
New
The role will be based in Palo Alto, CA or be remote and reports to the Director, Clinical ... Assists CRAs in ensuring eTMF completeness, eTMF audit findings and resolutions. * Manages and/or ...
New
Quick apply
The role will be based in Palo Alto, CA or be remote and reports to the Director, Clinical ... Assists CRAs in ensuring eTMF completeness, eTMF audit findings and resolutions. * Manages and/or ...
New
$32.75 - $44.75/hr
Fortrea's FSP Team is hiring a TMF Lead II! Remote US. Seeking strong experience in heavy metrics ... electronic TMF (eTMF) and supporting Inspection Readiness goals in compliance with ICH/GCP ...
$32.75 - $44.75/hr
Fortrea's FSP Team is hiring a TMF Lead II! Remote US. Seeking strong experience in heavy metrics ... electronic TMF (eTMF) and supporting Inspection Readiness goals in compliance with ICH/GCP ...
Clinical Project Lead, Oncology
Durham, NC · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Durham, NC · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Atlanta, GA · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Atlanta, GA · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Atlanta, GA · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Atlanta, GA · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Parsippany, NJ · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Parsippany, NJ · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Parsippany, NJ · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Parsippany, NJ · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Durham, NC · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Durham, NC · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Philadelphia, PA · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Philadelphia, PA · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Philadelphia, PA · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Clinical Project Lead, Oncology
Philadelphia, PA · Remote
$68K - $232K/yr
In this remote role you will serve as the primary country-level leader for clinical trial delivery ... Ensure inspection readiness through complete and accurate trial documentation (CTMS, eTMF)
Conduct remote, risk-based, and on-site monitoring tasks, including source data verification (SDV ... High proficiency in modern clinical trial systems including EDC, eTMF, and CTMS, as well as MS ...
Conduct remote, risk-based, and on-site monitoring tasks, including source data verification (SDV ... High proficiency in modern clinical trial systems including EDC, eTMF, and CTMS, as well as MS ...
Managed Services Consultant - Life Sciences (Remote)
$70K - $140K/yr
This is a remote, full-time permanent role with Veeva. There is no work location requirement. This ... EMC, Liquent, and/or Next Docs, eTMF/CTMS solutions Interviewing with Veeva * Follow the ...
Managed Services Consultant - Life Sciences (Remote)
$70K - $140K/yr
This is a remote, full-time permanent role with Veeva. There is no work location requirement. This ... EMC, Liquent, and/or Next Docs, eTMF/CTMS solutions Interviewing with Veeva * Follow the ...
Remote Etmf information
What is a remote eTMF?
A Remote eTMF (electronic Trial Master File) job involves managing and maintaining digital clinical trial documentation from a remote location. Professionals in this role ensure regulatory compliance, organize essential trial records, and facilitate audits. They work with sponsors, CROs, and regulatory bodies to ensure proper documentation throughout a clinical study. Strong knowledge of GCP (Good Clinical Practice) guidelines and document management systems is typically required. This role is essential in supporting the smooth execution of clinical trials while ensuring regulatory requirements are met.
What are the main daily responsibilities of a remote eTMF?
As a Remote eTMF Specialist, your daily responsibilities typically include uploading, reviewing, and maintaining essential clinical trial documents within electronic Trial Master File systems to ensure proper organization and compliance. You will regularly collaborate with clinical project teams, regulatory personnel, and external partners to track document statuses and resolve any discrepancies. Ensuring all documentation meets internal quality standards and regulatory requirements is a key focus. This role also often involves preparing the eTMF for audit and inspection readiness, which requires strong attention to detail and proactive communication.
What are the key skills and qualifications needed to thrive in the remote eTMF position, and why are they important?
To thrive as a Remote eTMF (electronic Trial Master File) Specialist, you need strong knowledge of clinical trial documentation, GCP (Good Clinical Practice) compliance, and previous experience working in clinical research or regulatory affairs. Proficiency with eTMF systems such as Veeva Vault, Medidata, or MasterControl, along with familiarity with regulatory guidelines, is typically required. Excellent attention to detail, organizational skills, and effective remote communication abilities set top candidates apart. These skills ensure that clinical trial documentation is accurate, audit-ready, and compliant with regulations in a virtual work environment.
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Full-time
Re-posted 26 days ago
Job description
Our client seeks an Business Analyst Veeva Vault Clinical (CTMS/eTMF) for a Full Time Project in Remote . Below is the detailed requirement
Job Title: Business Analyst Veeva Vault Clinical (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, of Client legacy CTMS Gilda (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
Job Title: Business Analyst Veeva Vault Clinical (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 10-12+ years of experience delivering or leading regulated enterprise or 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
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
- Ensure documentation is complete, accurate, and aligned with intended business outcomes, system behavior, and regulatory expectations
- Act as a translator between technical and business audiences, validating that documentation clearly reflects scope, assumptions, risks, and downstream impacts
- 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, of Client legacy CTMS Gilda (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
- Siebel CTMS experience, particularly in migration or decommissioning efforts
- Experience with system integrations, APIs, middleware, and data platforms
- 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