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Freelance Trial Master File Jobs in Arizona (NOW HIRING)

BD Mexico

Clinical Safety Specialist

Tempe, AZ · On-site

$100 - $125/hr

Perform study and/or site-level audits of the Trial Master File (TMF) to ensure that Clinical Safety related study files are current, accurate, complete and audit-ready. * Develop and/or complete ...

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Freelance Trial Master File information

What is a freelance trial master file?

A Freelance Trial Master File (TMF) specialist is an independent professional who manages and maintains the Trial Master File for clinical trials. The TMF is an organized collection of essential documents that demonstrate the compliance of a clinical trial with regulatory requirements and Good Clinical Practice (GCP) guidelines. Freelance TMF specialists typically work on a contract basis with pharmaceutical companies, contract research organizations (CROs), or clinical trial sponsors to ensure that all trial documentation is complete, accurate, and audit-ready.

What are the key skills and qualifications needed to thrive as a freelance trial master file specialist?

To thrive as a Freelance Trial Master File Specialist, you need a strong understanding of clinical trial documentation, regulatory requirements (such as ICH-GCP), and experience in managing TMF processes. Familiarity with electronic TMF (eTMF) systems, document management tools, and possibly certifications like DIA's TMF Management certificate are typically required. Excellent organizational skills, attention to detail, and effective communication are crucial soft skills for ensuring document accuracy and stakeholder collaboration. These skills are vital for maintaining compliant, audit-ready TMFs that support successful clinical trial execution and regulatory submissions.

What are some common challenges faced by freelance trial master file professionals, and how can they be addressed?

Freelance TMF professionals often encounter challenges such as maintaining document consistency across multiple studies and sponsors, adapting to various electronic TMF (eTMF) systems, and ensuring compliance with evolving regulatory requirements. To address these challenges, it's essential to develop strong organizational skills, stay current with industry regulations like ICH-GCP, and become proficient in commonly used eTMF platforms. Regular communication with sponsors and clinical teams also helps resolve discrepancies quickly and ensures timely document submission.

What are the most commonly searched types of Trial Master File jobs in Arizona?

The most popular types of Trial Master File jobs in Arizona are:

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For Freelance Trial Master File jobs in Arizona, the most frequently searched job titles are:

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The top searched job categories for Freelance Trial Master File jobs in Arizona are:

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Freelance Trial Master File jobs near you

Manager Sponsor Regulatory Affairs & Institutional Trial Compliance

Honorhealth

Scottsdale, AZ • On-site

Full-time

Re-posted 20 days ago

HonorHealth rating

7.8

Company rating: 7.8 out of 10

Based on 211 frontline employees who took The Breakroom Quiz

137th of 898 rated healthcare providers

Job description

Primary City/State:

Shea Medical Office Building - 10197 N 92nd St Scottsdale, AZ 85258

Category:

Research Operations

Shift:

Day

Department:

HRI-Translational Research

Monday-Friday

Great care starts with great people. (Like you.)

At HonorHealth, you'll find something special. From humble beginnings in 1927 to one of Arizona's largest nonprofit healthcare systems, our culture is built on warmth and neighborly kindness. Behind every smile is a highly skilled professional with deep expertise and an unwavering dedication to what matters most - caring for the health and well-being of people and communities across the greater Phoenix area.

Responsibilities:

JOB SUMMARY

Provides strategic and operational leadership for the Office of Regulatory Affairs and Research Oversight in the Division of Institutional Research, responsible for sponsor regulatory oversight of institutionally sponsored clinical trials conducted throughout the health system. Ensures full compliance with FDA regulations, ICH Good Clinical Practice, federal requirements, state requirements, and institutional policies governing sponsor responsibilities. Leads regulatory infrastructure that supports trial startup, conduct, safety oversight, multi-site expansion, reporting obligations, quality systems, and inspection readiness. Partners across the enterprise to create an efficient, scalable, and high performing sponsored trials program.

ESSENTIAL FUNCTIONS
  • Sponsor Regulatory Strategy and Agency Compliance:Lead implementation of regulatory strategy for institutionally sponsored clinical trials, including drug, device, biologic, behavioral, and observational studiesDetermine regulatory pathway for each study, including IND, IDE, exempt, abbreviated, or non-FDA regulated statusOversee preparation and submission of INDs, IDEs, amendments, annual reports, safety reports, protocol changes, and closeout filings as requiredServe as primary institutional contact with FDA and other regulatory agencies regarding sponsor mattersMonitor changes in regulations, guidance, and enforcement trends, then implement required operational changesEnsure fulfillment of sponsor commitments, reporting deadlines, and regulatory obligationsProvides guidance to leadership on regulatory risk, escalation items, and remediation strategy.
  • Trial Startup, Lifecycle Management, and Sponsor Oversight:Lead sponsor regulatory and compliance startup processes from concept approval through study activationOversee regulatory readiness for protocol finalization, informed consent documents, investigator qualifications, site documents, and essential regulatory recordsApprove activation of internal and external participating sites once sponsor requirements are metDirect amendment implementation processes across all participating sitesOversee study closeout, final reporting, archival readiness, and record retention requirementsSupport expansion of institutional trials into multi-site networks and affiliated partnersEnsure delegation of sponsor responsibilities to CROs, monitors, vendors, or external partners is documented and controlledEnsure trial institutional reporting requirements such as to CT.Gov, registration and reporting are completed within the institutional regulatory guidelines.
  • Safety Oversight, Quality Systems, and Inspection Readiness:Establish sponsor systems for adverse event review, serious adverse event reporting, unanticipated problem management, and safety signal escalationCoordinate oversight bodies such as DSMBs, independent medical monitors, adjudication committees, and safety review committees when requiredMaintain sponsor Trial Master File standards, completeness, version control, and inspection readinessEnsure regulatory data fields are complete in electronic research support systemPartner with Data Manager to conduct IND/IDE tracking and create reporting dashboardsPartner with Quality Assurance, Compliance, IRB, and operational leaders on audits, monitoring findings, CAPAs, and corrective actionsLead internal audit readiness program and conduct mock FDA inspectionsLead preparation for FDA inspections, sponsor audits, and external regulatory reviewsIdentify systemic compliance risks and implement preventive controls
  • Governance, Policy, Training, and Enterprise Collaboration:Develop and maintain sponsor SOPs, work instructions, templates, governance charters, and operational standardsCreate standardized pathways for investigator initiated and institutionally sponsored trialsEducate investigators, research staff, executives, and operational departments on sponsor obligations and regulatory expectationsPartner with IRB, legal, contracting, finance, pharmacy, laboratory, privacy, data governance, and revenue cycle teams to align study operationsAdvise investigators on regulatory and institutional compliance documentation needs during protocol development to improve feasibility and regulatory successPromote a culture of accountability, service, compliance, and operational excellence across the research enterprise
  • Leadership, Talent Management, and Financial Stewardship:Build, lead, mentor, and evaluate a high performing sponsor regulatory affairs teamEstablish staffing models aligned with institutional trial volume and complexityWork with project coordinators to set performance metrics for study startup timelines, as it pertains to regulatory and compliance documentationDevelop and manage departmental operating and capital budgetsIdentify efficiencies, automation opportunities, and scalable systems that improve productivity and reduce cycle timesProvide regular dashboards and strategic updates to executive leadershipSupport long term growth of the institutional sponsored trial portfolio

EDUCATION
  • Bachelors Required
  • Masters in health administration, public health, regulatory science, business, nursing, pharmacy, law, or related field Preferred

EXPERIENCE
  • 6 years, of progressive clinical research experience Required
  • 3 years, of leadership experience in regulatory affairs, sponsor operations, quality systems, or clinical trial administration Required
  • 3 years, of experience with IND, IDE, FDA submissions, or sponsor held trials Preferred
  • 3 years, of experience building teams, systems, and operational infrastructure Preferred

LICENSE AND CERTIFICATIONS
  • Society of Clinical Research Associates CCRP Preferred
  • Association of Clinical Research Professionals CCRC Preferred
  • Regulatory Affairs Professionals Society RAC Preferred
  • PMP Preferred

We're all in for your career.

What HonorHealth employees say

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About HonorHealth

Sourced by ZipRecruiter

HonorHealth is a non-profit, local community healthcare system serving an area of 1.6 million people in the greater Phoenix area. The network encompasses six acute-care hospitals, an extensive medical group, outpatient surgery centers, a cancer care network, clinical research, medical education, a foundation, and community services with approximately 13,100 team members, 3,500 affiliated providers and nearly 700 volunteers. HonorHealth was formed by a merger between Scottsdale Healthcare and John C. Lincoln Health Network. HonorHealth's mission is to improve the health and well-being of those we serve.

Industry

Health care and social assistance

Company size

10,000+ Employees

Headquarters location

Scottsdale, AZ, US

Year founded

2014

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