Clinical Research TMF Documentation Specialist

A highly reputable health corporation is currently hiring a qualified Clinical Research TMF Documentation Specialist to work a hybrid schedule in Chicago, IL.

Trial Master File (TMF) Specialist will assist in and oversee all aspects of TMF Management. The role oversees collection, quality assessment, processing and archiving of clinical trials documents from both external and internal sources.The TMF Specialist is responsible for ensuring standard service level agreements in relation to TMF Specialist are maintained and supports the definition, implementation, execution and process improvement of TMF Management activities.

Duties and Responsibilities:

eTMF Specialist is responsible for leading the design and set-up of the electronic Trial Master File (eTMF) systemLead, design, build and develop Trial Master File structure per applicable regulatory guidanceBuild and develop study specific eTMFs with appropriate security permissionsDevelop and refine eTMF workflow/tactical executionPopulate eTMFs with required essential documentsAuthor/co-author required content and training for eTMF as neededDevelop and execute plan for superseded documents in eTMFSupport eTMF related tasks as directedManage daily tasks and refine electronic data captures (EDCs) based on business and study needsAct as Subject Matter Expert for eTMF management.Ensure suitable reports and outputs are built to support TMF Quality.Provide day to day document management support.Perform and manage TMF Quality reviews and drive for constant inspection readiness of TMFs.Serve as point of contact and support study teams for resolution of TMF-related queries or quality issues.

Qualifications:

Bachelor’s Degree in science or relevant experience in health tech / clinical research.5+ years of relevant FDA documentation experience.Previous experience working with and building eTMFs required.Strong knowledge of eTMF structure, content, essential documents, naming conventions and documentation management required.Solid understanding of ICH-GCP guidelines and regulatory requirements related to clinical document management / eTMFs.Strong interpersonal skill sand ability to manage at all levels within a cross-functional organization through influence.Continuous improvement mindset and ability to function independently with a proactive, self-starter attitude.Ability to handle a high volume of complex tasks with a given timeline.

Preferred:Experienced with cardiac domain specific clinical trialsExperienced with EDCs

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