... Trial Master File standards, completeness, version control, and inspection readiness Ensure regulatory data fields are complete in electronic research support system Partner with Data Manager to ...
... Trial Master File standards, completeness, version control, and inspection readiness Ensure regulatory data fields are complete in electronic research support system Partner with Data Manager to ...
... Trial Master File standards, completeness, version control, and inspection readinessEnsure regulatory data fields are complete in electronic research support systemPartner with Data Manager to ...
... Trial Master File standards, completeness, version control, and inspection readinessEnsure regulatory data fields are complete in electronic research support systemPartner with Data Manager to ...
Clinical Safety Coordinator
Tempe, AZ · On-site
Support Trial Master File (TMF) maintenance for Clinical Safety documentation and perform study and/or site-level audits to ensure that study files are current, accurate, complete and audit-ready.
Clinical Safety Coordinator
Tempe, AZ · On-site
Support Trial Master File (TMF) maintenance for Clinical Safety documentation and perform study and/or site-level audits to ensure that study files are current, accurate, complete and audit-ready.
Support Trial Master File (TMF) maintenance for Clinical Safety documentation and perform study and/or site-level audits to ensure that study files are current, accurate, complete and audit-ready.
Support Trial Master File (TMF) maintenance for Clinical Safety documentation and perform study and/or site-level audits to ensure that study files are current, accurate, complete and audit-ready.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Clinical Research Associate, Sponsor Dedicated
Paradise Valley, AZ · On-site
$71K - $189K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Clinical Research Associate, Sponsor Dedicated
Paradise Valley, AZ · On-site
$71K - $189K/yr
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP ...
Clinical Project Coordinator
Tempe, AZ · On-site
... Trial Master File (TMF) maintenance and perform study and/or site-level audits to ensure that study files are current, accurate, complete and audit-ready. * Assist with study and site-level ...
Clinical Project Coordinator
Tempe, AZ · On-site
... Trial Master File (TMF) maintenance and perform study and/or site-level audits to ensure that study files are current, accurate, complete and audit-ready. * Assist with study and site-level ...
Clinical Project Coordinator
Tempe, AZ · On-site
... with Trial Master File (TMF) maintenance and perform study and/or site-level audits to ensure that study files are current,accurate,completeand audit-ready. * Assistwith study and site-level ...
Clinical Project Coordinator
Tempe, AZ · On-site
... with Trial Master File (TMF) maintenance and perform study and/or site-level audits to ensure that study files are current,accurate,completeand audit-ready. * Assistwith study and site-level ...
Clinical Safety Specialist
Tempe, AZ · On-site
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 ...
Clinical Safety Specialist
Tempe, AZ · On-site
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 ...
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 ...
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 ...
Clinical Research Coordinator
Scottsdale, AZ · On-site
$24.50 - $32.50/hr
Complete new trial feasibilities upon review with potential Investigator and submit to Sponsor/CRO ... Ensure duplication of each for filing in the subject source and with the regulatory specialist.
Clinical Research Coordinator
Scottsdale, AZ · On-site
$24.50 - $32.50/hr
Complete new trial feasibilities upon review with potential Investigator and submit to Sponsor/CRO ... Ensure duplication of each for filing in the subject source and with the regulatory specialist.
Clinical Research Coordinator
Scottsdale, AZ · On-site
$24.50 - $32.50/hr
Complete new trial feasibilities upon review with potential Investigator and submit to Sponsor/CRO ... Ensure duplication of each for filing in the subject source and with the regulatory specialist.
Clinical Research Coordinator
Scottsdale, AZ · On-site
$24.50 - $32.50/hr
Complete new trial feasibilities upon review with potential Investigator and submit to Sponsor/CRO ... Ensure duplication of each for filing in the subject source and with the regulatory specialist.
ESIS Claims Associate
Phoenix, AZ · On-site
$17.50 - $23.75/hr
Continue efforts to settle claims before trial. * Participate in claim file reviews and audits with ... Bachelor's/Master's degree or equivalent experience. * Proficient in Microsoft Word, Excel, and ...
ESIS Claims Associate
Phoenix, AZ · On-site
$17.50 - $23.75/hr
Continue efforts to settle claims before trial. * Participate in claim file reviews and audits with ... Bachelor's/Master's degree or equivalent experience. * Proficient in Microsoft Word, Excel, and ...
ESIS Claims Associate
Phoenix, AZ · On-site
$47K - $67K/yr
Continue efforts to settle claims before trial. * Participate in claim file reviews and audits with customers/insureds and brokers. Qualifications * Bachelor's/Master's degree or equivalent ...
ESIS Claims Associate
Phoenix, AZ · On-site
$47K - $67K/yr
Continue efforts to settle claims before trial. * Participate in claim file reviews and audits with customers/insureds and brokers. Qualifications * Bachelor's/Master's degree or equivalent ...
... master of administrative tasks. You have pronounced attention to detail and are obsessed with ... You will be responsible for scanning, filing, and completing tasks within Clinical Trial Management ...
... master of administrative tasks. You have pronounced attention to detail and are obsessed with ... You will be responsible for scanning, filing, and completing tasks within Clinical Trial Management ...
... master of administrative tasks. You have pronounced attention to detail and are obsessed with ... You will be responsible for scanning, filing, and completing tasks within Clinical Trial Management ...
Quick apply
... master of administrative tasks. You have pronounced attention to detail and are obsessed with ... You will be responsible for scanning, filing, and completing tasks within Clinical Trial Management ...
... master of administrative tasks. You have pronounced attention to detail and are obsessed with ... You will be responsible for scanning, filing, and completing tasks within Clinical Trial Management ...
... master of administrative tasks. You have pronounced attention to detail and are obsessed with ... You will be responsible for scanning, filing, and completing tasks within Clinical Trial Management ...
Clinical Research Assistant
Phoenix, AZ · On-site
... master of administrative tasks. You have pronounced attention to detail and are obsessed with ... filing, data entry, and completing tasks within Clinical Trial Management Software (CTMS)
Quick apply
Clinical Research Assistant
Phoenix, AZ · On-site
... master of administrative tasks. You have pronounced attention to detail and are obsessed with ... filing, data entry, and completing tasks within Clinical Trial Management Software (CTMS)
... master of administrative tasks. You have pronounced attention to detail and are obsessed with ... filing, data entry, and completing tasks within Clinical Trial Management Software (CTMS)
... master of administrative tasks. You have pronounced attention to detail and are obsessed with ... filing, data entry, and completing tasks within Clinical Trial Management Software (CTMS)
... master of administrative tasks. You have pronounced attention to detail and are obsessed with ... You will be responsible for scanning, filing, and completing tasks within Clinical Trial Management ...
... master of administrative tasks. You have pronounced attention to detail and are obsessed with ... You will be responsible for scanning, filing, and completing tasks within Clinical Trial Management ...
Trial Master File information
See Phoenix, AZ salary details
$11.22 - $17.06
4% of jobs
$17.06 - $22.90
9% of jobs
$25.89 is the 25th percentile. Wages below this are outliers.
$22.90 - $28.75
24% of jobs
The median wage is $33.96 / hr.
$28.75 - $34.59
15% of jobs
$34.59 - $40.43
16% of jobs
$44.38 is the 75th percentile. Wages above this are outliers.
$40.43 - $46.28
11% of jobs
$46.28 - $52.12
10% of jobs
$52.12 - $57.96
8% of jobs
$57.96 - $63.80
0% of jobs
$63.80 - $69.65
2% of jobs
$69.65 - $75.49
2% of jobs
$11
$38
$75
How much do trial master file jobs pay per hour?
What is a trial master file?
A Trial Master File (TMF) job involves managing and maintaining essential documents related to clinical trials to ensure compliance with regulatory requirements. Professionals in this role organize, track, and audit critical trial documentation to support inspections and submissions. They work closely with clinical teams, sponsors, and regulatory authorities to ensure proper documentation is accurate, complete, and audit-ready throughout the trial lifecycle.
What are the typical responsibilities and daily tasks of a trial master file specialist?
As a TMF Specialist, your main responsibilities include managing, organizing, and maintaining all essential clinical trial documentation to ensure compliance with regulatory standards. On a daily basis, you will review and upload documents to eTMF systems, track document status, resolve discrepancies, and support study teams during audits or inspections. You'll collaborate closely with clinical research associates, project managers, and quality assurance teams to ensure the TMF is complete and inspection-ready at all times. The work is detail-oriented and deadline-driven, offering opportunities to develop expertise in regulatory standards and advance into roles such as TMF Manager or Clinical Trial Associate.
What are the key skills and qualifications needed to thrive in the trial master file position, and why are they important?
To thrive in a Trial Master File (TMF) Specialist role, you need meticulous organizational skills, comprehensive knowledge of regulatory requirements for clinical trials, and often a bachelor's degree in life sciences or a related field. Familiarity with electronic Trial Master File (eTMF) systems, document management platforms, and relevant GCP (Good Clinical Practice) certifications is commonly required. Attention to detail, proactive communication, and the ability to collaborate effectively across clinical research teams are key soft skills. These competencies ensure regulatory compliance and seamless documentation, which are critical for the successful conduct and audit-readiness of clinical trials.
What are the most commonly searched types of Trial Master File jobs in Phoenix, AZ?
The most popular types of Trial Master File jobs in Phoenix, AZ are:
What are popular job titles related to Trial Master File jobs in Phoenix, AZ?
For Trial Master File jobs in Phoenix, AZ, the most frequently searched job titles are:
What job categories do people searching Trial Master File jobs in Phoenix, AZ look for?
The top searched job categories for Trial Master File jobs in Phoenix, AZ are:
- Clinical Data Manager
- Remote Animal Health
- History Research
- Entry Level Clinical Research
- Entry Level Clinical Data Manager
- Contractual Contract Clinical Research
- Director Clinical Research Operations
- Remote Clinical Trial Operations
- Remote Tribe Clinical Research
- Vice President Clinical Research Pharmaceutical

Manager Sponsor Regulatory Affairs & Institutional Trial Compliance
Scottsdale, AZ • On-site
7.7
Based on 209 frontline employees who took The Breakroom Quiz
159th of 893 rated healthcare providers
People enjoy working here
Good employer
Recommended by students
Recommended by parents
Respectful managers
Full-time
Re-posted 6 days ago
Job description
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 studies
Determine regulatory pathway for each study, including IND, IDE, exempt, abbreviated, or non-FDA regulated status
Oversee preparation and submission of INDs, IDEs, amendments, annual reports, safety reports, protocol changes, and closeout filings as required
Serve as primary institutional contact with FDA and other regulatory agencies regarding sponsor matters
Monitor changes in regulations, guidance, and enforcement trends, then implement required operational changes
Ensure fulfillment of sponsor commitments, reporting deadlines, and regulatory obligations
Provides 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 activation
Oversee regulatory readiness for protocol finalization, informed consent documents, investigator qualifications, site documents, and essential regulatory records
Approve activation of internal and external participating sites once sponsor requirements are met
Direct amendment implementation processes across all participating sites
Oversee study closeout, final reporting, archival readiness, and record retention requirements
Support expansion of institutional trials into multi-site networks and affiliated partners
Ensure delegation of sponsor responsibilities to CROs, monitors, vendors, or external partners is documented and controlled
Ensure 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 escalation
Coordinate oversight bodies such as DSMBs, independent medical monitors, adjudication committees, and safety review committees when required
Maintain sponsor Trial Master File standards, completeness, version control, and inspection readiness
Ensure regulatory data fields are complete in electronic research support system
Partner with Data Manager to conduct IND/IDE tracking and create reporting dashboards
Partner with Quality Assurance, Compliance, IRB, and operational leaders on audits, monitoring findings, CAPAs, and corrective actions
Lead internal audit readiness program and conduct mock FDA inspections
Lead preparation for FDA inspections, sponsor audits, and external regulatory reviews
Identify 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 standards
Create standardized pathways for investigator initiated and institutionally sponsored trials
Educate investigators, research staff, executives, and operational departments on sponsor obligations and regulatory expectations
Partner with IRB, legal, contracting, finance, pharmacy, laboratory, privacy, data governance, and revenue cycle teams to align study operations
Advise investigators on regulatory and institutional compliance documentation needs during protocol development to improve feasibility and regulatory success
Promote 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 team
Establish staffing models aligned with institutional trial volume and complexity
Work with project coordinators to set performance metrics for study startup timelines, as it pertains to regulatory and compliance documentation
Develop and manage departmental operating and capital budgets
Identify efficiencies, automation opportunities, and scalable systems that improve productivity and reduce cycle times
Provide regular dashboards and strategic updates to executive leadership
Support 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.
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
Website
What HonorHealth employees say
Pay
Benefits
Hours and flexibility
Workplace
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