Vectorious has developed the world’s first in-heart microcomputer and is on a mission to transform heart failure treatment. As part of our first in-human clinical study, we have successfully implanted our sensory device in patients across Europe, while demonstrating a huge potential in helping millions of people living with heart failure to take control and manage their disease. As an increasingly growing company we’ve been accepted to FDA’s prestige Breakthrough Device Designation program.
We are looking for a talented CTA to join out Clinical departement
What will you do?:
- Support clinical study documentation preparation, tracking and maintenance.
- Support clinical study coordinators with study related data (questionnaires scores etc.)
- Maintain and perform periodic review of in-house study site records for completeness and accuracy.
- Prepare and send study-related documents and materials to sites, CROs or development partners.
- Assist in the preparation and maintenance of Clinical Study Agreements and Confidentiality Agreements
- Develop and maintain effective tracking systems to ensure updates of regulatory documents.
- Initiate request for investigator, site, and vendor payments
- Help facilitate shipment study supplies to study sites.
- Maintain and organize reference materials related to the study.
- Maintain systems to track study metrics and general study information.
- Coordinate logistics and materials of formal meetings as needed (e.g. data review meetings and centralized investigator meetings)
- Attend study, project, and departmental meetings.
- Support development of relevant tracking tools and other internal processes to increase departmental efficiency.
- Onsite activities as per need, activities such as site initiation visit, ISF review and others
- Support other job-related duties as assigned by the CTM or designer.
What do you need to bring with you?:
- Bachelor’s degree in a related scientific discipline
- Working knowledge of GCPs, Trial Master Files, ICH guidelines or experience working in a regulated environment
- Professional demeanor and ability to work as a team member.
- Experience with MS Office Suite (Word, PowerPoint, Excel, Project)
- Ability to coordinate and prioritize multiple tasks.
- An inherent quality for end-to-end tasks management
- Good problem-solving skills
- Good written and verbal skills in English