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Tmf Manager Remote Jobs in California (NOW HIRING)

Diality

Clinical Research Associate

Irvine, CA · Remote

$120K - $135K/yr

Maintain and organize the Trial Master File (TMF) and ensure all essential documents are current ... Experience with managing remote monitoring activities or decentralized clinical trials.

ICON

Senior Clinical Research Associate

Los Angeles, CA · On-site +1

$110K - $138K/yr

Manage site essential document collection and TMF reconciliation with site files * Support sites ... and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials. * 1+ years ...

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Tmf Manager Remote information

What is the difference between Tmf Manager Remote vs Tmf Coordinator?

AspectTmf Manager RemoteTmf Coordinator
CredentialsTypically requires advanced certifications and experience in TMF managementUsually requires basic TMF knowledge, often with entry-level certifications
Work EnvironmentRemote, strategic oversight, team managementRemote or onsite, focused on document review and data entry
Industry UsageUsed in clinical research, pharmaceutical companies, CROsCommon in clinical trial sites, CROs, and pharma companies

The Tmf Manager Remote oversees TMF processes at a strategic level, managing teams and ensuring compliance, while the Tmf Coordinator handles day-to-day document management tasks. Both roles are essential in clinical research but differ in scope, responsibilities, and required experience.

What are common challenges faced by a remote TMF manager, and how can they be addressed?

As a remote TMF (Trial Master File) Manager, one common challenge is ensuring consistent communication and collaboration with global clinical teams, especially when working across different time zones. Maintaining TMF quality and compliance can also be more complex when overseeing dispersed teams and vendors. To address these challenges, it's important to establish clear processes, utilize robust electronic TMF systems, and schedule regular virtual check-ins to monitor progress and address issues proactively. Building strong relationships with team members and providing thorough training on regulatory requirements also helps maintain high standards and project alignment.

What skills and qualifications are needed to thrive as a TMF manager?

To thrive as a TMF Manager (Remote), you need strong knowledge of clinical trial documentation, regulatory requirements (such as ICH-GCP), and experience with Trial Master File (TMF) management, typically supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, document management platforms, and relevant certifications like DIA’s TMF Practitioner are common requirements. Exceptional organizational skills, attention to detail, and effective remote communication abilities are crucial soft skills for this role. These competencies ensure regulatory compliance, the integrity of clinical trial documentation, and smooth collaboration across geographically dispersed teams.

What is a TMF manager?

A TMF (Trial Master File) Manager is a professional responsible for overseeing the collection, organization, and maintenance of essential documents related to clinical trials, ensuring compliance with regulatory requirements. Working remotely, a TMF Manager uses electronic systems to coordinate documentation across multiple sites and teams, monitor document quality, and ensure audit readiness. Their role is critical for maintaining the integrity and accessibility of clinical trial records, which are essential for regulatory submissions and inspections.
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Infographic showing various Tmf Manager Remote job openings in California as of August 2026, with employment types broken down into 100% Full Time. Highlights an 8% Hybrid, and 92% Remote job distribution.

Sr. Clinical Research Associate (US)

Alimentiv

San Francisco, CA • On-site, Remote

Full-time

Posted 3 days ago

New

Job description

Independently performs, coordinates and oversees all aspects of the clinical site monitoring services, assessing protocol and regulatory compliance as per Alimentiv's and sponsor's standard processes, ICH/GCP guidelines and local regulation. Serves as the primary liaison between the sponsor/Alimentiv and investigative sites by playing a critical role in the execution of clinical study plans. Provides guidance and mentoring CRA I and II, collaborating effectively with cross-functional stakeholders in a dynamic, results-driven and high-accountability environment. Perform CRA Assessment Visits and participate in audits/inspections, when required.
Site Monitoring activities (55-60%)
  • Independently conduct and document onsite and remote activities, including site monitoring and close-out visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance.
  • Collaborate with site staff to review and ensure that the data reported in the applicable study system(s) is consistent with the source documents and compliant with study requirements.
  • Monitor, resolve and/or facilitate resolution of data queries and escalate issues as appropriate.
  • Coordinate the shipment of clinical supplies, including but not limited to, investigational product, laboratory supplies, ePROs and study documents.
  • Ensures site staff is trained in all aspects of the study including but not limited to the protocol, study plans, systems and ICH-GCP.
  • Participate in routine study progress meetings, teleconferences, and Investigator's meetings.
  • Routinely review ISF and TMF for accuracy, timeliness, and completeness. Request documents from the site, as required.

Site Management activities (15-20%)
  • Act as a primary contact for any questions or issues that arise from investigational sites.
  • Oversee overall integrity of the study and promote positive working relationships with the site staff and study team members.
  • Facilitate and support site staff with access to study systems and ensure sites are compliant with project specific training requirements.
  • Ensure all site related issues are followed until resolution, including action items and protocol deviations.
  • Coordinate delivery of clinical sites communications, collaborating with project teams, to ensure investigational sites are provided accurate ongoing data, updates, information and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.
  • Regularly review the study related systems remotely to ensure compliance, accuracy and completeness.
  • Translate site documents for TMF filing when applicable.
  • Routinely review the TMF for accuracy, timeliness, and completeness. Request documents from the site, as required.
  • Coordinate the shipment of clinical supplies, including but not limited to, investigational product, laboratory supplies, ePROs and study documents.
  • Participate in audits/inspections and follow-up on issues and implement actions, when required.
  • Participate in routine study progress meetings and teleconferences.

Site Recruitment and Setup (15-20%)
  • Identify and advise on site investigators selection, independently conduct and document onsite and remote activities, including site qualification and initiation visits. Ensure that all activities are documented in accordance with applicable SOPs and study guidance.
  • Coordinate the shipment and delivery of clinical supplies, including but not limited to laboratory supplies, study documents and investigational product.
  • Responsible for all site management activities related to site activation and work with the sites to meet clinical project timelines and milestones.
  • Support the study Start-up team by following up on pending documents, as needed.
  • Support the Regulatory team by reviewing, localizing and translating site documents, as required.
  • Optimize patient recruitment providing guidance and support to site teams to meet the site recruitment milestones.
  • Participate in Investigator's meetings.

Mentoring and Internal Initiatives (5-10%)
  • Mentor and support CRA I and II.
  • Perform CRA Assessment Visits, co-monitoring visits or visit sign-off process, providing feedback.
  • Assist the MSM hiring Manager by participating in interviews with candidates for the CRA position, as requested.
  • Participate in process improvement initiatives and contribute to the development of best practices.

Qualifications
  • The successful candidate will possess a minimum of a college diploma/degree and 4-6 years of related experience.
  • Ability to regularly travel to sites.
  • Proficient in using EDC systems (e.g., Medidata Rave, Oracle InForm), IRT, eTMF, CTMS, and Microsoft Office Suite.
  • Ability to travel up to 40-60%, depending on project assignment and geographic location of sites.
  • Strong interpersonal and problem-solving skills; able to work independently and within cross-functional teams.
  • Great communication and organizational skills, detailed orientation and sense of urgency are required.

Working Conditions
  • Home-based
  • Regular travel is required

$86,000 - $143,000 a year
+bonus
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