eTMF Specialist (Contract role)
Chicago
Clinical /
Hybrid /
Hybrid
Cardiosense is a digital health company that operates at the intersection of wearable technology and artificial intelligence to improve patient health. Our mission is to use physiological waveform data to predict cardiac illness and enable early interventions so people can enjoy healthier, longer lives.
To achieve our mission we are building a physiological waveform AI platform to develop predictive biomarkers to detect and manage cardiac disease. The company has developed a suite of novel digital tools, multi-sensor devices, and analysis algorithms for use by care providers to detect clinical worsening earlier, inform personalized therapy, and improve patient outcomes.
Our team brings together experts in data science, electronics, and healthcare and has partnered with leading healthcare and academic institutions to introduce the next generation of patient waveform monitoring and analytics solutions.
About the role:
The eTMF Specialist is responsible for leading the design and set-up of the Cardiosense electronic Trial Master File (eTMF) system. This role is a contract position, estimated for between 3-6 months.
What you’ll be doing:
- Lead, design, build and develop Trial Master File structure per applicable regulatory guidance
- Build and develop study specific eTMFs with appropriate security permissions
- Develop and refine eTMF workflow/tactical execution
- Populate eTMFs with required essential documents
- Author/co-author required content and training for eTMF as needed
- Develop and execute plan for superseded documents in eTMF
- Support eTMF related tasks as directed
- Manage daily tasks and refine electronic data captures (EDCs) based on business and study needs
Qualifications:
- Bachelor’s degree in science or relevant experience in healthtech/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
Preferred:
- Experience with cardiac domain specific clinical trials
- Experience routing through AoDocs
- Experience with EDCs
Cardiosense is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, ethnicity, religion, disability status, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
