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• Process clinical study documentation in accordance with SOPs, FDA, and ICH GCP guidelines. • Perform quality-control (QC) review of clinical and regulatory documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted. • Assist with the development of work processes and systems to support document management, including contributing to SOPs and internal department guidance. • Administrate user access for the eTMF software and maintain access documentation. • Provide support and training to team members on processes and eTMF software. • Assist the clinical team in the close-out and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. • Process and fulfill document requests from external stakeholders for studies which have been archived in the eTMF/eISF. • Assist with periodic review of study files for completeness.
• We need you to have awareness of applicable clinical research regulatory requirements - ICH GCP, along with familiarity with the documents used in clinical trials at both the TMF and ISF level. You should be able to demonstrate a willingness to work in a fast-paced environment juggling workload with time pressures. The ability to establish and maintain effective working relationships with coworkers, managers, and clients is key and you should have good written and verbal communication skills as well as working knowledge of computer applications such as Word, Excel, and PowerPoint. • Understanding and knowledge of current industry regulations and guidelines. • Familiarity with ICH GCP, DIA TMF Reference Model and regulatory guidelines/directives. • Familiarity with eTMF and CTMS software for document management activities preferred. • Ability to learn and apply SOPs and process governance regulations pertaining to clinical study documentation. • Strong organizational/communication skills and attention to detail. • Expertise in Microsoft Office Suite and Adobe Acrobat.
• The Clinical Document Specialist is responsible for supporting Trial Master File (TMF) set-up, maintenance, closure, and transfer for clinical projects at TrialSpark. This role will also act as the superuser and administrator for the eTMF platform that TrialSpark uses.
• Minimum 5 years’ experience working with Clinical Documentation in a TMF platform (or comparable operating experience) in medical device, pharma/biotech, CRO, or healthcare environment(s) required. • Two years of demonstrable records management experience, specifically eTMF experience in clinical research field.
• The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $100M+. And the problem is only getting worse. • TrialSpark is a technology company that brings new medical treatments to patients faster. We’re reimagining the clinical trial by introducing a new model, using technology to streamline every aspect of the trial. To fulfill our mission, we partner with pharma, biotech, and digital health companies to run studies faster and more efficiently.
• You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
• The role is anticipated to be a 40 hour commitment for at least 4 months.
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