Clinical eTMF Consultant - Arnex Solutions LLC - | Dice.com

Arnex Solutions LLC

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Clinical eTMF Consultant

• Posted 5 hours ago • Updated 4 hours ago

Contract Independent

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Arnex Solutions LLC

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Job Details

Skills

Veeva Vault
Clinical Operations
Electronic Trial Master File
MasterControl
ICH-GCP

Summary

Job Title: Clinical eTMF Consultant

Department: Clinical Operations

Position Summary:

The Clinical eTMF Specialist is responsible for managing and maintaining the Electronic Trial Master File (eTMF) system to ensure compliance with regulatory requirements, internal quality standards, and study timelines. This role ensures that all clinical trial documentation is complete, accurate, and inspection-ready at all times. The eTMF Specialist serves as a key liaison between Clinical Operations, Quality Assurance, Regulatory Affairs, and external partners such as CROs and vendors.

Key Responsibilities:

Oversee setup, configuration, and ongoing management of the eTMF system for assigned clinical studies.
Ensure that all essential documents are filed accurately and in accordance with ICH-Google Cloud Platform, 21 CFR Part 11, and company SOPs.
Perform quality control (QC) checks on uploaded documents to ensure completeness, accuracy, and proper metadata tagging.
Monitor TMF completeness metrics and collaborate with study teams to close gaps or resolve discrepancies.
Train study team members and CROs on eTMF best practices, workflows, and compliance expectations.
Support inspection readiness activities and participate in audits (internal and external).
Generate and distribute TMF metrics and reports to stakeholders on a routine basis.
Partner with IT or vendor support teams to troubleshoot eTMF system issues and support upgrades or enhancements.
Maintain TMF Index mapping and document naming conventions across studies.
Contribute to continuous improvement of TMF processes and SOPs.

Qualifications:

Education:

Bachelor's degree in Life Sciences, Healthcare, Information Management, or a related field.

Experience:

2 5 years of experience managing Trial Master Files (TMF/eTMF) within a pharmaceutical, biotech, or CRO environment.
Familiarity with eTMF platforms (e.g., Veeva Vault, PhlexTMF, Wingspan, MasterControl, or similar).
Solid understanding of ICH-Google Cloud Platform guidelines and regulatory documentation requirements.
Experience supporting audits and inspections (FDA, EMA, MHRA, etc.).

Skills:

Strong attention to detail and organizational skills.
Proficient in document management systems and metadata handling.
Excellent written and verbal communication skills.
Ability to work effectively across cross-functional teams in a global environment.

Preferred Qualifications:

eTMF certification or experience as an eTMF Administrator.
Experience with clinical systems integration (CTMS, EDC, etc.).
Knowledge of Quality Management Systems (QMS).
Prior experience supporting clinical study start-up and close-out activities.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91124621
Position Id: 2025-176/955
Posted 5 hours ago

Company Info

About Arnex Solutions LLC

At Arnex Solutions LLC, we go beyond traditional consulting. We blend expertise with innovation to offer end-to-end solutions that bridge the gap between business challenges and technological advancements.

Our Services:
Strategic IT Advisory: Our experienced consultants collaborate with you to craft customized IT strategies that drive growth and efficiency. We transform technology into a competitive advantage.

Talent Resourcing: Access top IT talent with ease. Our staffing solutions connect you with skilled professionals who align with your unique business requirements.

Cloud Excellence: Leverage the power of the cloud with our tailored services. From strategy to execution, we help you harness cloud capabilities for innovation and scalability.
Why Choose Arnex Solutions LLC:

Holistic Approach: We're your all-in-one partner for both strategic consulting and talent acquisition. Our holistic solutions ensure your business stays ahead in a dynamic landscape.

Client-Centric Philosophy: Your success is at the heart of everything we do. Our collaborative approach ensures we understand your unique needs and deliver impactful solutions.

Innovation Infused: We embrace emerging technologies to drive innovation. Partnering with Arnex Solutions LLC means accessing solutions that position you for sustained success.

Enduring Partnerships: Our commitment extends beyond a single project. When you choose Arnex Solutions LLC, you choose a partner dedicated to your long-term growth.

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