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Etmf Veeva Jobs in Silver Spring, MD (NOW HIRING)

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Etmf Veeva information

What are the key skills and qualifications needed to thrive as an eTMF Veeva specialist?

To thrive as an eTMF Veeva Specialist, you need strong knowledge of clinical trial documentation management, regulatory compliance, and experience with electronic Trial Master File (eTMF) systems, often backed by a degree in life sciences or a related field. Proficiency in Veeva Vault eTMF software, along with familiarity with tools like SharePoint or other document management systems, is typically required. Attention to detail, organization, and strong communication skills are essential soft skills for this role. These abilities ensure accurate documentation, regulatory readiness, and efficient collaboration across clinical trial teams.

What are the main challenges an eTMF Veeva specialist might face when implementing Veeva Vault systems in a clinical trial environment?

An eTMF Veeva specialist often encounters challenges such as ensuring high data quality and compliance with regulatory standards while managing large volumes of documentation across multiple study sites. Integrating Veeva Vault with existing workflows and training diverse teams on system usage can also be complex, as each clinical study may have unique requirements. Strong communication and project management skills are essential, as the role often involves collaborating with clinical operations, regulatory, and IT teams to resolve issues and streamline processes.

What is the difference between Etmf Veeva vs Clinical Data Coordinator?

AspectEtmf VeevaClinical Data Coordinator
CertificationsVeeva Vault certifications, life sciences knowledgeClinical research certifications, data management training
Work EnvironmentPharmaceutical/biotech companies, cloud-based platformsClinical trial sites, CROs, pharmaceutical companies
Industry UsageUsed for document management and eTMF processes in life sciencesManages clinical trial data, ensures data quality and compliance

While both roles operate within the clinical research industry, Etmf Veeva specialists focus on managing electronic Trial Master Files using Veeva Vault, emphasizing document control and compliance. Clinical Data Coordinators handle clinical trial data collection and validation, ensuring data accuracy. Understanding these differences helps employers and professionals identify the right skills and certifications for each role.

What is an eTMF Veeva specialist?

An eTMF Veeva specialist manages electronic Trial Master File (eTMF) systems using the Veeva Vault platform, which is widely used in the pharmaceutical and clinical research industries. Their responsibilities include ensuring that clinical trial documents are properly collected, organized, and compliant with regulatory standards. They also provide training and support to staff using the eTMF system and help maintain data integrity throughout the trial process. This role is essential for maintaining audit readiness and streamlining document management in clinical operations.
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Etmf Veeva jobs near you
Infographic showing various Etmf Veeva job openings in Silver Spring, MD as of August 2026, with employment types broken down into 93% Full Time, and 7% Contract. Highlights an 65% In-person, 9% Hybrid, and 26% Remote job distribution.

In-House Clinical Research Associate

Technical Resources International, Inc

Bethesda, MD • On-site

Full-time

Re-posted 16 days ago

Job description

Job Title
In-House Clinical Research Associate
Location
Bethesda, MD 20817 US (Primary)
Category
Clinical Operations
Job Type
Full-Time
Salary Range
50,000-80,000
Education
Bachelor's Degree
Travel
None
Job Description
The In-House Clinical Research Associate is responsible for supporting clinical study teams, primarily the field CRAs and the Project/Task Manager, as required on clinical trial administrative duties. Duties may include but are not limited to:
  • Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file platform or system held by TRI or Sponsor/Client.
  • Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP, Sponsor requirements, and corporate or Sponsor SOPs.
  • Track essential regulatory documents in a centralized web-based system and/or other database.
  • Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems.
  • Coordinate or assist in distribution of trial-related materials to study sites.
  • May assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation.

NOTE: Specialized experience in eTMF (e.g., Veeva Vault) processing and system administration skills-sets and/or additional responsibilities may be required for some staff. This job may serve as a transition or training role for the position of field CRA, as appropriate.
Job Requirements
  • Understanding of medical and clinical trials terminology.
  • Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution.
  • Able to work independently or with minimal supervision as well as within a team.
  • Excellent attention to detail with organizational and prioritization skills for efficient productivity.
  • Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum).
  • Excellent professional writing and verbal communication skills (position requires clear phone and email communication).
  • Able to multi-task during the review/processing and preparation of essential regulatory documentation.
  • Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right.
  • Must have excellent time management skills, able to adhere to strict timelines and expectations.
  • Experience with regulatory document review/collection and IRB submissions (including OHRP regulations), a plus.
  • Experience with using a Trial Master File, a plus.
  • This is a hybrid position with 2 days in TRI's Bethesda, Maryland office, and 3 days working remotely.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.

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