Document Coordinator
Cambridge, MA · On-site
The primary purpose of this job is to provide support for document approval/finalization and preparation for publishing; submission of documents to clinical study Trial Master File and QC of Trial ...
Document Coordinator
Cambridge, MA · On-site
The primary purpose of this job is to provide support for document approval/finalization and preparation for publishing; submission of documents to clinical study Trial Master File and QC of Trial ...
Excellent employment opportunity for a Specialist Study Management in the Wilmington, DE area ... Operational responsibility to set-up the local Trial Master File (eTMF) including tracking of ...
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Excellent employment opportunity for a Specialist Study Management in the Wilmington, DE area ... Operational responsibility to set-up the local Trial Master File (eTMF) including tracking of ...
Specialist Study Management
$33.75 - $45.25/hr
Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents. Maintain and close the local TMF (in electronic or paper form ...
Specialist Study Management
$33.75 - $45.25/hr
Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents. Maintain and close the local TMF (in electronic or paper form ...
Clinical Trial Manager
$125K - $143K/yr
Manage Trial Master File (TMF) documentation. * Coordinate study working groups and stakeholder meetings. * Ensure ClinicalTrials.gov registration and reporting requirements are met. * Monitor study ...
Clinical Trial Manager
$125K - $143K/yr
Manage Trial Master File (TMF) documentation. * Coordinate study working groups and stakeholder meetings. * Ensure ClinicalTrials.gov registration and reporting requirements are met. * Monitor study ...
Spec 3, Clinical Research
Irvine, CA · On-site
Medical
Life
Retirement
... Specialist supports all phases of clinical studies, including study start-up, conduct, and closeout, with a primary focus on maintaining an audit- and inspection-ready Trial Master File (TMF). This ...
Spec 3, Clinical Research
Irvine, CA · On-site
Medical
Life
Retirement
... Specialist supports all phases of clinical studies, including study start-up, conduct, and closeout, with a primary focus on maintaining an audit- and inspection-ready Trial Master File (TMF). This ...
Clinical Trial Manager
Frederick, MD · On-site
$125K - $143K/yr
Manage Trial Master File (TMF) documentation. * Coordinate study working groups and stakeholder meetings. * Ensure ClinicalTrials.gov registration and reporting requirements are met. * Monitor study ...
Quick apply
Clinical Trial Manager
Frederick, MD · On-site
$125K - $143K/yr
Manage Trial Master File (TMF) documentation. * Coordinate study working groups and stakeholder meetings. * Ensure ClinicalTrials.gov registration and reporting requirements are met. * Monitor study ...
Clinical Trial Manager
Berkeley, CA · On-site +1
Medical
Dental
Vision
Retirement
PTO
Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness * Review and/or approve site-specific documents, including informed consent forms ...
Clinical Trial Manager
Berkeley, CA · On-site +1
Medical
Dental
Vision
Retirement
PTO
Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness * Review and/or approve site-specific documents, including informed consent forms ...
Clinical Trial Manager
Berkeley, CA · On-site +1
Medical
Dental
Vision
Retirement
PTO
Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness * Review and/or approve site-specific documents, including informed consent forms ...
Clinical Trial Manager
Berkeley, CA · On-site +1
Medical
Dental
Vision
Retirement
PTO
Maintain and oversee the Trial Master File (TMF), ensuring completeness, quality, and continuous inspection readiness * Review and/or approve site-specific documents, including informed consent forms ...
eTrial Master File Senior Analyst
Lawrenceville, NJ · On-site
$122K - $122K/yr
Scientific - eTrial Master File Senior Analyst Research and Development/Global Clinical Compliance ... Work closely with Global Trial Managers and TMF Study Leads to support the completeness of the TMF ...
eTrial Master File Senior Analyst
Lawrenceville, NJ · On-site
$122K - $122K/yr
Scientific - eTrial Master File Senior Analyst Research and Development/Global Clinical Compliance ... Work closely with Global Trial Managers and TMF Study Leads to support the completeness of the TMF ...
Senior TMF Lead
King Of Prussia, PA · On-site
... Trial Master File. It's the evidence base regulators, auditors, and inspectors turn to when they ... In parallel, you'll work regularly with the Study File Specialists working across studies. Cross ...
Senior TMF Lead
King Of Prussia, PA · On-site
... Trial Master File. It's the evidence base regulators, auditors, and inspectors turn to when they ... In parallel, you'll work regularly with the Study File Specialists working across studies. Cross ...
Senior TMF Lead
King Of Prussia, PA · On-site
... Trial Master File. It's the evidence base regulators, auditors, and inspectors turn to when they ... In parallel, you'll work regularly with the Study File Specialists working across studies. Cross ...
Senior TMF Lead
King Of Prussia, PA · On-site
... Trial Master File. It's the evidence base regulators, auditors, and inspectors turn to when they ... In parallel, you'll work regularly with the Study File Specialists working across studies. Cross ...
Senior TMF Lead
King Of Prussia, PA · Hybrid
... Trial Master File. It's the evidence base regulators, auditors, and inspectors turn to when they ... In parallel, you'll work regularly with the Study File Specialists working across studies. Cross ...
Senior TMF Lead
King Of Prussia, PA · Hybrid
... Trial Master File. It's the evidence base regulators, auditors, and inspectors turn to when they ... In parallel, you'll work regularly with the Study File Specialists working across studies. Cross ...
Senior TMF Lead
King Of Prussia, PA · On-site
... Trial Master File. It's the evidence base regulators, auditors, and inspectors turn to when they ... In parallel, you'll work regularly with the Study File Specialists working across studies. Cross ...
Senior TMF Lead
King Of Prussia, PA · On-site
... Trial Master File. It's the evidence base regulators, auditors, and inspectors turn to when they ... In parallel, you'll work regularly with the Study File Specialists working across studies. Cross ...
Senior TMF Lead
King Of Prussia, PA · On-site
... Trial Master File. It's the evidence base regulators, auditors, and inspectors turn to when they ... In parallel, you'll work regularly with the Study File Specialists working across studies. Cross ...
Senior TMF Lead
King Of Prussia, PA · On-site
... Trial Master File. It's the evidence base regulators, auditors, and inspectors turn to when they ... In parallel, you'll work regularly with the Study File Specialists working across studies. Cross ...
Senior Clinical Trial Associate
$110K - $115K/yr
Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents * Assists in ...
Senior Clinical Trial Associate
$110K - $115K/yr
Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents * Assists in ...
Sr. Clinical Trial Associate (Hybrid - Acton, MA)
$37 - $50.25/hr
Medical
Dental
Vision
Retirement
PTO
Trial Master File (TMF) & Documentation Own the ongoing oversite, maintenance, quality, and completeness of the electronic Trial Master File (eTMF) in accordance with regulatory and internal ...
Sr. Clinical Trial Associate (Hybrid - Acton, MA)
$37 - $50.25/hr
Medical
Dental
Vision
Retirement
PTO
Trial Master File (TMF) & Documentation Own the ongoing oversite, maintenance, quality, and completeness of the electronic Trial Master File (eTMF) in accordance with regulatory and internal ...
Senior Clinical Trial Associate
$100K - $115K/yr
Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents * Assists in ...
Senior Clinical Trial Associate
$100K - $115K/yr
Ensures receipt, completeness, accuracy, and appropriate filing (Trial Master File, study SharePoint, other study or Olema-specific systems) of clinical and administrative documents * Assists in ...
Clinical Trials Associate
San Carlos, CA · On-site
$40.50 - $55.25/hr
Trial Master File (TMF) * Assist with the management and quality control of electronic Trial Master Files (eTMFs). * Review documents for completeness, accuracy, and TMF filing readiness. * Support ...
Clinical Trials Associate
San Carlos, CA · On-site
$40.50 - $55.25/hr
Trial Master File (TMF) * Assist with the management and quality control of electronic Trial Master Files (eTMFs). * Review documents for completeness, accuracy, and TMF filing readiness. * Support ...
Clinical Trials Associate
San Carlos, CA · On-site
$40.50 - $55.25/hr
Trial Master File (TMF) * Assist with the management and quality control of electronic Trial Master Files (eTMFs). * Review documents for completeness, accuracy, and TMF filing readiness. * Support ...
Clinical Trials Associate
San Carlos, CA · On-site
$40.50 - $55.25/hr
Trial Master File (TMF) * Assist with the management and quality control of electronic Trial Master Files (eTMFs). * Review documents for completeness, accuracy, and TMF filing readiness. * Support ...
TMF Operations Lead
OR · On-site +1
$33.50 - $45.75/hr
As our Trial Master File expert, you'll partner with Clinical Operations and cross-functional teams to build high-quality TMFs, identify and address risks early, and help ensure our studies are ...
TMF Operations Lead
OR · On-site +1
$33.50 - $45.75/hr
As our Trial Master File expert, you'll partner with Clinical Operations and cross-functional teams to build high-quality TMFs, identify and address risks early, and help ensure our studies are ...
Trial Master File Specialist information
What is a trial master file specialist?
A Trial Master File (TMF) Specialist is responsible for managing and maintaining the Trial Master File, a collection of essential documents required for clinical trials. They ensure compliance with regulatory guidelines, organize and track documents, and support audit readiness. TMF Specialists work closely with clinical teams, sponsors, and regulatory authorities to facilitate efficient document management. Their role is critical in ensuring the integrity, accuracy, and completeness of clinical trial documentation.
What skills and qualifications are needed to thrive as a trial master file specialist?
To thrive as a Trial Master File Specialist, you need strong organizational skills, attention to detail, a solid understanding of clinical research regulations (such as GCP/ICH), and often a bachelor's degree in a life science field. Experience with electronic Trial Master File (eTMF) systems and knowledge of regulatory compliance tools or certifications like DIA TMF Reference Model are highly valued. Effective communication, problem-solving abilities, and the capacity to collaborate with cross-functional teams are key soft skills for success. These qualifications ensure the integrity, completeness, and audit-readiness of clinical trial documentation, which is critical for regulatory compliance and successful trial outcomes.
What are common challenges a trial master file specialist faces in their daily work?
Trial Master File Specialists often encounter challenges such as managing large volumes of documentation from multiple sources, ensuring that files remain current and audit-ready, and keeping up with evolving regulatory requirements. Coordinating with various stakeholders—including clinical operations, site staff, and quality assurance—to obtain missing or incomplete documents can require strong communication and follow-up skills. The role demands meticulous attention to deadlines and detail to avoid compliance gaps, and specialists must be comfortable working with specialized eTMF systems. Successfully navigating these challenges is crucial for maintaining high standards of data integrity and ensuring clinical trial readiness for inspections.
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Job description
Company Description
A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
Job Description
Job Summary:
The primary purpose of this job is to provide support for document approval/finalization and preparation for publishing; submission of documents to clinical study Trial Master File and QC of Trial Master File, including remediation
Principal Accountabilities:
Assist Medical Writing Operations staff with document approval and notification processes and maintenance of the Trial Master File, including submission of documents and routine QC and remediation. 90%
Assist Medical Writing staff with document formatting/troubleshooting/reference management. 10%
Impacts quality of clinical documentation. Liaises with staff across Development Sciences and Global Medical.
Knowledge & Skills:
Advanced Microsoft Office skills (Word, PowerPoint, Excel); familiarity with Adobe, Documentum, other systems as needed.
Strong attention to detail.
Ability to multitask in a fast-paced environment.
Excellent oral and written communication skills.
Aptitude for learning new systems and technology.
Familiarity with the clinical development process, understanding of trial master file.
Qualifications
Minimum Education Requirements: Associate's Degree required; Bachelor's Degree preferred.
Minimum Experience Requirements: 1+ year experience in biotech or pharmaceutical company (R&D, Clinical preferred).
Additional Information
With Regards,
Kavita Kumari
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Inc. 5000 - 2007-2014 (8th Year)
Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70
Tel: 732-549-2030 x208
Fax: 732-549-5549
Direct: 732-549-5302
www.irionline.com
https://www.linkedin.com/in/rkavita
About Integrated Resources
Sourced by ZipRecruiter
Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.
Industry
Recruiting and staffing services
Company size
51 - 200 Employees
Headquarters location
Edison, NJ, US
Year founded
1996