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Remote Etmf Jobs in Oregon (NOW HIRING)

Clinical Study Manager (Remote)

OR · Remote

$84K - $110K/yr

Remote Salary Range: Salary Minimum: $84,000.00 Salary Maximum: $110,000.00 Arthrex, Inc. is a ... design, eTMF design, CTMS design and user testing for assigned studies. * Provide centralized ...

Remote Etmf information

What is a Remote eTMF job?

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 Specialist?

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.

What are the most commonly searched types of Etmf jobs in Oregon? The most popular types of Etmf jobs in Oregon are:
What are popular job titles related to Remote Etmf jobs in Oregon? For Remote Etmf jobs in Oregon, the most frequently searched job titles are:
Clinical Study Manager (Remote)

Clinical Study Manager (Remote)

ARTHREX

OR • Remote

$84K - $110K/yr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 6 days ago


Arthrex rating

8.2

Company rating: 8.2 out of 10

Based on 75 frontline employees who took The Breakroom Quiz

80th of 527 rated manufacturers


Job description

Location: Remote     Salary Range: Salary Minimum: $84,000.00 Salary Maximum:  $110,000.00

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Clinical Study Manager. This individual will be responsible for leading and supporting clinical studies and projects aligned with Arthrex Research's clinical research initiatives. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better.

This is a fully remote opportunity.

Essential Duties and Responsibilities:

  • Planning, executing, managing, and oversight of clinical studies and projects according to Research ethics guidelines, ISO standards, internal SOPs, and portfolio priorities.
  • Serve as a cross-functional lead within an assigned study portfolio, ensuring alignment across Clinical Operations, Product Management, Data Management, Regulatory, Compliance, and other key stakeholders.
  • Provide accurate, timely status reports and portfolio-level updates on assigned clinical research studies and projects.
  • Facilitate appropriate documentation to maintain compliance with the AP and Compliance department for HCP transfers of value.
  • Facilitate clinical contract agreements between Arthrex and the Site for studies.
  • Assist the data management team with electronic data capture systems CRF design, eTMF design, CTMS design and user testing for assigned studies.
  • Provide centralized communication and coordination between research sites and internal cross-functional stakeholders.
  • Facilitate site training for data collection clinical research initiatives.
  • Monitor data collection compliance and communicate with sites to optimize data collection.
  • Provide the main line of communication with research sites.
  • Facilitate IRB approval at the site and sponsor level.
  • Oversee and approve site activation activities for studies, ensuring readiness across all functional areas.
  • Collaborate on reviewing protocols, case report forms, and informed consent for clinical studies.
  • Qualify sites for participation in assigned studies.
  • Complete central, remote, and on-site monitoring visits, reports, and follow-up letters.
  • Identify study- and portfolio-level risks or issues, implement mitigation strategies, and develop CAPA plans as appropriate.
  • Works closely with the other clinical research professionals and cross-functional partners to ensure successful study execution.
  • Conduct regular investigator meetings to ensure protocol compliance and site engagement.
  • Actively participate in research committees, study groups, and cross-functional portfolio governance activities to support continuous improvement and strategic alignment.
  • Engage in and support departmental initiatives and cross-functional team projects, collaborating by driving execution, problem-solving, and achievement of key business outcomes.

Knowledge and Skill Requirements/Specialized Courses and/or Training: 

  • Strong strategic thinking with the ability to translate goals into actionable project plans.
  • An understanding of cross-functional clinical study processes is required.
  • Good communication, documentation, and record-keeping skills are required.
  • Ability to identify a research hypothesis and proposed outcomes measures to address the hypothesis is required.
  • Ability to read surgical techniques and have a basic understanding of the medical devices necessary to perform the procedure is required.
  • Experience managing research contracts and protocol development is preferred.
  • Able to communicate effectively with physicians, key opinion leaders, and other healthcare personnel.
  • Experience in post-market, real world evidence, longitudinal or health economics studies is preferred.
  • Ability to generate and develop ideas that drive efficiency and impact organizational goals.
  • Ability to approach challenges with an innovative, solution-oriented mindset.

Education and Experience:

  • Bachelor's degree required.
  • 4 years of relevant clinical research experience required.
  • Familiarity with orthopedic terminology is preferred.
  • One year of industry sponsor or CRO employment preferred.
  • Clinical Research Certification required, or must be willing to obtain within 1 year of employment.

Machine, Tools, and/or Equipment Skills:

  • Experience in Microsoft Office, Clinical trial Electronic Data Capture systems, and electronic trial master file is required.
  • Experience in clinical trial management systems is preferred.

Arthrex Benefits

  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Gym Reimbursement Program
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.


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