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Remote Trial Master File Jobs in Baltimore, MD (NOW HIRING)

ICON

Senior Clinical Research Associate

Baltimore, MD · On-site +1

... trial team and the sites * Perform remote and on-site monitoring/co-monitoring visits (Site ... Manage site essential document collection and TMF reconciliation with site files * Support sites ...

Stouffer Legal

Senior Document Review Attorney

Towson, MD · Remote

$140K - $200K/yr

... to master new areas of law * Highly experienced in estate plan drafting, with strong knowledge of ... is a remote position. Company Description Join our dynamic team and become a part of an ...

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How much do remote trial master file jobs pay per hour?

As of Aug 21, 2026, the average hourly pay for remote trial master file in Baltimore, MD is $17.62, according to ZipRecruiter salary data. Most workers in this role earn between $15.77 and $18.85 per hour, depending on experience, location, and employer.

What is a remote Trial Master File and what does the role involve?

A Remote Trial Master File (TMF) professional is responsible for managing and maintaining essential documents related to clinical trials in a digital or remote environment. This role ensures that all regulatory and compliance requirements are met by organizing, tracking, and archiving important trial documentation. Working remotely, TMF specialists collaborate with clinical research teams, auditors, and regulatory authorities to ensure data integrity and readiness for inspections. The job often involves using specialized electronic TMF (eTMF) systems to facilitate secure access and management of files from different locations.

What are the key skills and qualifications needed to thrive as a remote Trial Master File specialist?

To thrive as a Remote Trial Master File (TMF) Specialist, you need a solid understanding of clinical trial processes, regulatory requirements (such as ICH-GCP), and experience with TMF management, often supported by a degree in life sciences or a related field. Familiarity with electronic TMF (eTMF) systems, document management software, and compliance tracking tools is typically required. Attention to detail, organizational skills, and strong communication are vital soft skills to ensure accurate documentation and effective collaboration across remote teams. These skills and qualifications are crucial for maintaining regulatory compliance, ensuring data integrity, and supporting the smooth conduct of clinical trials.

What are the main challenges of managing a Trial Master File remotely, and how can they be addressed?

Managing a TMF remotely often presents challenges such as maintaining document version control, ensuring regulatory compliance, and facilitating timely collaboration across dispersed teams. To address these, many organizations utilize secure cloud-based eTMF systems that allow real-time access and updates, implement clear document management protocols, and schedule regular virtual check-ins with team members. Strong communication skills and familiarity with electronic documentation tools are essential for success in this remote environment.

What is the difference between Remote Trial Master File vs Clinical Trial Associate?

AspectRemote Trial Master FileClinical Trial Associate
CredentialsTypically requires knowledge of GCP, ICH guidelines, and document managementRequires knowledge of clinical trial processes, GCP, and data entry
Work EnvironmentRemote, document management systems, cloud-based platformsOffice or site-based, assisting with trial coordination and data collection
Industry UsageUsed across pharmaceutical, biotech, and CROs for document oversightCommonly employed in clinical research teams for trial support

The Remote Trial Master File focuses on managing and maintaining essential trial documents remotely, ensuring compliance and accessibility. In contrast, a Clinical Trial Associate supports trial activities on-site or remotely, handling data collection and coordination. Both roles are vital in clinical research but differ mainly in scope and responsibilities.

What are the most commonly searched types of Trial Master File jobs in Baltimore, MD?

The most popular types of Trial Master File jobs in Baltimore, MD are:

What are popular job titles related to Remote Trial Master File jobs in Baltimore, MD?

For Remote Trial Master File jobs in Baltimore, MD, the most frequently searched job titles are:

What job categories do people searching Remote Trial Master File jobs in Baltimore, MD look for?

The top searched job categories for Remote Trial Master File jobs in Baltimore, MD are:

What cities near Baltimore, MD are hiring for Remote Trial Master File jobs?

Cities near Baltimore, MD with the most Remote Trial Master File job openings:

Remote Trial Master File jobs near you

Director of Regulatory Affairs - REMOTE

i4 Search Group Healthcare

Baltimore, MD • Remote

$80K - $100K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted yesterday

Job description

Job Description: Director of Regulatory Affairs


Location: Remote (U.S.-Based) - Any Location

Employment Type: Full-Time


Position Summary

We are seeking an experienced and detail-oriented Director of Regulatory Affairs to lead regulatory operations supporting clinical research activities. This role will oversee a team of Clinical Research Coordinators (CRCs) and regulatory staff while ensuring compliance with federal regulations, sponsor requirements, institutional policies, and Good Clinical Practice (GCP) guidelines.

The Regulatory Affairs Supervisor will serve as a key liaison between investigators, sponsors, contract research organizations (CROs), and regulatory agencies to support the successful execution of clinical trials from study startup through closeout.


Key Responsibilities

Regulatory Leadership & Oversight

  • Supervise and mentor regulatory coordinators and Clinical Research Coordinators (CRCs).
  • Ensure compliance with FDA regulations, ICH-GCP guidelines, HIPAA requirements, and institutional policies.
  • Oversee preparation, submission, and maintenance of regulatory documents for clinical trials.
  • Manage regulatory activities throughout the study lifecycle, including startup, amendments, continuing reviews, reportable events, and study closeout.
  • Maintain regulatory binders, essential documents, and study files to ensure audit readiness.


Clinical Trial Management Support

  • Collaborate with Principal Investigators, study teams, sponsors, and CROs to facilitate regulatory compliance and study execution.
  • Review study protocols, informed consent documents, investigator brochures, and sponsor communications.
  • Support site initiation, monitoring, audit, and closeout activities.
  • Track regulatory milestones and ensure timely submissions and approvals.


Team Supervision

  • Provide leadership, training, onboarding, and performance management for CRCs and regulatory personnel.
  • Establish workload priorities and ensure timely completion of regulatory deliverables.
  • Develop standard operating procedures (SOPs) and best practices to improve operational efficiency.
  • Foster a culture of quality, accountability, and continuous improvement.


Quality & Compliance

  • Conduct internal audits and quality reviews of study documentation.
  • Identify compliance risks and implement corrective and preventive actions (CAPAs).
  • Serve as a regulatory subject matter expert during sponsor audits, FDA inspections, and institutional reviews.
  • Monitor regulatory changes and communicate updates to research staff.


Required Qualifications

  • Bachelor's degree in Life Sciences, Healthcare Administration, Public Health, Nursing, Pharmacy, or related field.
  • 5+ years of experience supporting clinical research and regulatory affairs.
  • 2+ years of supervisory or team leadership experience.
  • Strong knowledge of:
  • FDA regulations
  • ICH-GCP guidelines
  • Human Subjects Protection requirements
  • IRB processes
  • Clinical trial operations
  • Experience managing regulatory submissions for multiple clinical studies.
  • Excellent organizational, communication, and project management skills.


Preferred Qualifications

  • Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or equivalent certification.
  • Experience with oncology, device, pharmaceutical, or multisite clinical trials.
  • Familiarity with CTMS, eRegulatory systems, and electronic document management platforms.
  • Experience supporting FDA inspections and sponsor audits.


Benefits

  • Fully remote work environment
  • Competitive salary
  • Medical, dental, and vision insurance
  • Paid time off and holidays
  • 401(k) with company match
  • Professional development opportunities
  • Career growth within a collaborative research organization


Ideal Candidate:

The ideal candidate is a proactive regulatory professional with strong clinical research experience who enjoys leading teams, ensuring compliance, and supporting high-quality clinical trial execution in a fast-paced remote environment.