ZipRecruiter

Log In

2

Remote Etmf Jobs (NOW HIRING)

Fortrea

Project Coordinator I, Phase I

Durham, CA · Remote

$30/hr

Remote based in United States. What You'll Do * Coordinate and support delivery of Phase I clinical ... Manage systems such as CTMS and eTMF, ensuring accuracy and compliance. * Act as a key point of ...

Merck & Co.

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data ... Manages and maintains information and documentation in CTMS, eTMF and various other systems as ...

Fortrea

$28 - $30/hr

Remote based in United States. What You'll Do * Coordinate and support delivery of Phase I clinical ... Manage systems such as CTMS and eTMF, ensuring accuracy and compliance. * Act as a key point of ...

Fortrea

Project Coordinator I, PC Academy

Durham, NC · Remote

$28 - $35/hr

Remote based in United States. What You'll Do * Coordinate and support delivery of Phase I clinical ... Manage systems such as CTMS and eTMF, ensuring accuracy and compliance. * Act as a key point of ...

Systimmune

Clinical Research Associate II

Princeton, NJ · Remote

$80K - $110K/yr

... and remote monitoring visits. * Excellent verbal and written communication skills required ... CTMS, EDC and eTMF) * Ability to travel as required (50-75%) Compensation and Benefits: The ...

Fortrea

Proficiency in Microsoft Office and familiarity with EDC, CTMS, eTMF, and vendor platforms (e.g. Veeva Vault, Medidata). * Effective leadership in remote and global environment. * Strong ...

previous pagenext page

Showing results 21-40

All JobsEtmf JobsRemote Etmf Jobs

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.

More about Remote Etmf jobs

What cities are hiring for Remote Etmf jobs?

Cities with the most Remote Etmf job openings:

What are the most commonly searched types of Etmf jobs?

The most popular types of Etmf jobs are:

What states have the most Remote Etmf jobs?

States with the most job openings for Remote Etmf jobs include:

What job categories do people searching Remote Etmf jobs look for?

The top searched job categories for Remote Etmf jobs are:

Remote Etmf jobs near you
Infographic showing various Remote Etmf job openings in the United States as of August 2026, with employment types broken down into 95% Full Time, and 5% Contract. Highlights an 100% Remote job distribution.

Manager, Pharmacovigilance Operations

Allogene Therapeutics

South San Francisco, CA • On-site, Remote

$140K - $150K/yr

Full-time

Medical

Posted 24 days ago

Job description

Job Description
About Allogene:
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
About the role:
We are seeking a highly motivated Manager, Pharmacovigilance Operations to join our team. You will provide support to the Allogene Pharmacovigilance department for drug safety operations including safety vendor oversight and management, serious adverse event reporting, support of study teams and projects, oversight of global safety database activities, and collaboration to support risk management and pharmacovigilance for all Allogene Therapeutics Clinical Trials and post marketing (where applicable). You will be interfacing cross-functionally at many levels in the organization as well as with our external vendors. You will be self-motivated, have strong communication and teamwork skills along with a robust ability to work independently, problem solve, manage work priorities, build collaborative relationships, and remain flexible to the needs of the teams and projects. This position will report to the Director, Pharmacovigilance. This role can be remote with frequent to travel to Allogene's South San Francisco headquarters or can be based out of our headquarters in South San Francisco, CA hybrid onsite 3 days a week.
Responsibilities include, but are not limited to:
  • Assist in Safety Vendor Oversight activities including tracking of KPIs, compliance metrics, and open query metrics.
  • Participate in eTMF filing for Allogene studies per TMF plans and procedures.
  • Schedule meetings and manage meeting agenda for PV team. Support Study Management Team meetings as needed.
  • Facilitate the preparation, completion, and submission of periodic safety reports (DSUR, 6M LL, etc.) and other regulatory filing documents.
  • Assist in MedDRA and WHODrug coding as needed.
  • Collaborate with the preparation and updates to safety section in the Investigator Brochures, RSI, DSURs, Protocols, ICFs, etc.
  • Manage Regulatory Reporting Requirements across all studies, ensure all requirements are met by the most current regulations.
  • Support projects or other initiatives from cross functional groups and departments
  • Support SPEED access requests and maintain the tracker, resolve access issues as applicable, perform monthly reconciliation.
  • Support SAE reconciliation between Clinical and Safety databases as needed.
  • Manage safety mailbox and provide responses to relevant communications.
  • Maintain internal and external distributions lists including providing updates and communications as appropriate.
  • Assist in the development and approval of PV SOPs and Work instructions
  • Initiate SMP review per schedule
  • Liaise with QA for CAPA activities in relation to, but not limited to, late SUSAR or aggregate report submissions as well as deviations relating to case management processes as defined per the SMPs or SOPs
  • Maintain SUSAR tracker in real time, perform monthly reconciliation and identify/resolve issues in timely manner.
  • Participate in regulatory inspections and PV audits to ensure quality, integrity and compliance with pharmacovigilance and safety reporting requirements
  • Other duties and projects as assigned

Position Requirements & Experience:
  • Bachelor's degree in life sciences, healthcare, or a related discipline; advanced degree (e.g., RN, BSN, PharmD) preferred
  • Minimum of 5 years of pharmacovigilance experience in a pharmaceutical or biotechnology company
  • Solid understanding and working knowledge of US and ex-US pharmacovigilance regulatory requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines)
  • Proficiency in safety databases and other systems (e.g., Oracle Argus, ARISg, MedDRA, WHODrug, SPEED)
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
  • Ability to work independently and collaboratively in a fast-paced environment and manage multiple projects simultaneously.
  • Experience with device safety reporting, eTMF filing, and regulatory inspections is a plus.
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
  • Candidates must be authorized to work in the U.S.

We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $140,000 to $150,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.
As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought, designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.
#LI-remote #LI-TF1

Apply