tmf

We are currently hiring full-time office based individuals for an exciting career in clinical research managing our Trial Master File. The Trial Master File (TMF) is a collection of documentation that allows the conduct of a clinical trial, and the integrity of the data produced to be evaluated by Regulatory bodies, such as the FDA. The TMF is an important...

The TMF Specialist is responsible for overseeing the overall management and quality of essential clinical trial documents to ensure compliance with applicable regulatory and local requirements. This position will provide management and oversight of Trial Master File (TMF) filing activities to ensure audit and inspection readiness for clinical...

DescriptionPosition Summary The TMF Lead is an independently resourceful subject matter expert (SME) responsible for the quality, completeness, and inspection readiness of Trial Master Files (TMFs) across assigned clinical studies, from study startup through study closeout and archive, within the Veeva TMF (Vault) system. Operating in a small biotech...

TMF SpecialistICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.As a TMF...

We are currently hiring full-time office based individuals for an exciting career in clinical research managing our Trial Master File. The Trial Master File (TMF) is a collection of documentation that allows the conduct of a clinical trial, and the integrity of the data produced to be evaluated by Regulatory bodies, such as the FDA. The TMF is an important...

Our Cambridge based client is seeking a detail-oriented TMF Manager to ensure their Trial Master Files (TMFs) are inspection-ready and aligned with ICH GCP and GDP standards. You’ll support internal teams and CROs in maintaining high-quality documentation across clinical studies.Key Responsibilities:Manage clinical document quality, control, and...

Lotus Clinical Research 100% Remote Who we are: www.lotuscr.comAbout the role:The TMF Specialist supports Regulatory Operations by managing, reviewing, and approving site-level documentation within the electronic Trial Master File (eTMF). This role ensures timely and accurate filing of essential documents, maintains audit readiness, and contributes to...

The TMF Specialist is responsible for overseeing the overall management and quality of essential clinical trial documents to ensure compliance with applicable regulatory and local requirements. This position will provide management and oversight of Trial Master File (TMF) filing activities to ensure audit and inspection readiness for clinical...

Company DescriptionA 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...

Company DescriptionA 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...

JOB DESCRIPTION: Job Summary The TMF Archivist is responsible for managing and overseeing Trial Master File (TMF) and record management activities, study closure, archival and retention. The role supports the compliant management of paper and electronic clinical trial records, TMF transfers and migrations, Investigator Site File (ISF) retention support, and...

Medpace Overview Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical...

Job descriptionWho We Are:TransPerfect is the world's largest provider of language services and technology solutions for global business. From offices in over 160 cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ TransPerfect's GlobalLink® technology to...

Description Owns Trial Master File (TMF) strategy, quality, inspection readiness, systems/processes, staff leadership, and client/study oversight.  Provide strategic and operational leadership for the organization’s TMF function, ensuring consistent inspection-ready trial documentation across several large-scale clinical programs and diverse...

Associate Director, Clinical Operations-TMF - (ADCOTMF_COMPANY_1.1) Job Title Associate Director, Clinical Operations-TMF Location Bethesda, MD 20817 US (Primary) Category Clinical Operations Job Type Full-Time Salary Range $130,000–$155,000/YR Education Master's Degree Travel None Job Description Owns Trial Master File (TMF) strategy,...

Job OverviewProject Leads are an integral part of clinical trial delivery, liaising with clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Project Lead is an essential member of the core project team responsible for project delivery of clinical studies to meet contractual requirements in accordance with SOPs,...

Technical Resources International, Inc. is seeking an Associate Director, Clinical Operations-TMF to lead TMF strategy and governance from Bethesda, MD, with a hybrid work arrangement. You will oversee TMF health across multiple trials, ensuring inspection readiness and regulatory alignment.The role requires senior leadership experience in TMF and a strong...

Mavericks Wanted  When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on   In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce...

COMPANY:At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we...

The TMF Senior Manager, Clinical Operations serves as the operational leader responsible for the strategy, governance, quality, and execution of the Trial Master File (TMF) across the clinical development portfolio. This role partners cross-functionally with Clinical Operations, Quality Assurance, Regulatory Affairs, Clinical Science, Biometrics, CROs, and...