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Etmf Veeva Jobs (NOW HIRING)

Skyhawk Therapeutics

Clinical Trial Associate

Waltham, MA · On-site

$75K - $140K/yr

Veeva TMF working knowledge and for senior level, demonstrated knowledge of ICH-GCP, FDA and international regulatory requirements, eTMF management/oversight, and inspection readiness * Demonstrated ...

Immunome, Inc.

Clinical Trial Associate

Bothell, WA · On-site

$37.50 - $51.25/hr

Hands-on experience managing trial documentation and TMF / eTMF processes; familiarity with common systems (e.g., Veeva Vault eTMF / CTMS or similar) preferred. * Experience supporting study start-up ...

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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 the United States as of August 2026, with employment types broken down into 89% Full Time, and 11% Contract. Highlights an 51% In-person, 9% Hybrid, and 40% Remote job distribution.

Clinical Trial Associate

Skyhawk Therapeutics

Waltham, MA • On-site

$75K - $140K/yr

Full-time

Re-posted 14 days ago

Job description

Clinical Trial Associate/ Senior Clinical Trial Associate
Skyhawk Therapeutics is seeking a highly motivated CTA to provide administrative and operational support to Clinical Operations.
Responsibilities (including, but not limited to):
  • Organize, participate in, and maintain agendas and meeting minutes for all internal and cross-functional team meetings. Review external meeting minutes as required.
  • Work closely with our clinical operations team to coordinate, track, and manage logistics in support of studies (e.g. review study plans, assist with eTMF reviews).
  • Update and maintain internal trackers (e.g. central enrollment tracker, investigator engagement tracker, bioanalytical sample tracker) and implement updates into ad-hoc presentations and reports as required.
  • Maintain internal Clinical Operations study files and perform periodic reconciliations of documents to ensure all material is present and versioned correctly.
  • Create and maintain study personnel contact lists for all studies and KOLs by disease indication.
  • Assist with the review of study-related documents for clinical studies (e.g. protocol, IB, ICFs).
  • Assist with the facilitation of important external meetings (e.g. Clinical Advisory Board meetings): outreach, scheduling, execution of CDAs and contracts, travel arrangements, presentations, agendas, and minutes.
  • Assist with bioanalytical sample tracking and management of central and third-party labs (sample shipment and analysis timelines).
  • Assist with the review of central and third-party lab documents (e.g. Lab Manual, site flowcharts).
  • Assist with monitoring trip report across the program.

Requirements, Education, Experience & Skills:
  • Relevant education and training required; Bachelor's degree in administrative, science or medical areas of study is a plus.
  • At least 3-5 years of successful administrative experience in biotech/life sciences, health care or clinical study management (title commensurate with experience, with emphasis on eTMF experience)
  • Prefers to contribute as both independent, self-starter, and a collaborative team member.
  • Excellent organizational skills; prefers and can adapt to multiple priorities in a fast-paced and fluid work environment.
  • Excellent verbal and written communication skills.
  • Excellent computer skills, including Microsoft Office Suite: Calendar, Word, Excel, and PowerPoint are essential. SharePoint and SmartSheet preferred.
  • Veeva TMF working knowledge and for senior level, demonstrated knowledge of ICH-GCP, FDA and international regulatory requirements, eTMF management/oversight, and inspection readiness
  • Demonstrated multi-tasking and project management skills.

Skyhawk Therapeutics is committed to pay transparency and equitable compensation practices. The base salary range for the Clinical Trial Associate is $75,000-140,000 annually. This range reflects the minimum and maximum target for such position. Skyhawk Therapeutics will assess the appropriate level for a qualified candidate based on job-related skills, professional experience, and relevant education or training.
About Skyhawk
Skyhawk is committed to discovering, developing and commercializing small molecule therapeutics that modify RNA expression. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world's most intractable diseases including neurological conditions, cancer, and traditionally "undruggable" targets.

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