Overview

“NoyMed LLC” is looking for a “Clinical Trial Manager”.

Responsibilities:


- Conduct prefeasibility research in specific therapeutic areas and provide reports to upper management
- Search, contact, organize, and conduct feasibility of sites, and labs and prepare feasibility reports for every particular project
- Participate in site and laboratory qualification activities as a subject matter expert and make a judgment of site/lab capabilities, experience, and compliance for any particular project
- Participate in client meetings and present the medical part of the project
- Guide the management and project teams regarding the medical part of projects
- Participate in project planning by coordinating scope and timelines with sites and laboratories
- Conduct site selection, initiation, and closing visits with the monitoring team
- Lead the day-to-day operations of assigned studies medical and safety teams to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
- Coordinate / lead vendors (sites, labs) within the project
- Conduct medical coding review
- Act as a medical monitor during clinical trials
- Conduct study monitoring visits and co-monitoring visits as needed
- Provide regular updates of study progression to the Clinical Project Manager and stakeholders; proactively identify and resolve issues that arise during study conduct; manage escalation of study-related issues
- Oversee the clinical aspects of timely data cleaning, data analysis, and the availability of top-line results; participate in data reviews
- Ensure set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external study team members

Required Qualifications:


- Advanced degree in Medicine, preferably in Ophthalmology, Oncology, Cardiology, Dermatology or General Medicine
- Work experience in clinical trials will be an advantage
- Deep understanding of clinical trial processes and requirements
- Thorough understanding of Good Clinical Practice/ICH Guidelines and any necessary regulatory requirements
- Strong organizational, prioritizing, negotiating, analytical, and problem-solving skills
- Excellent interpersonal and leadership skills
- Strong verbal and writing communication skills, including public speaking ability
- Excellent knowledge of English and Russian languages, both written and verbal
- Ability to work within the team and under pressure
- Excellent reporting skills
- Quick learner and self-starter, eager to learn and grow

About NoyMed LLC

NoyMed is a Contract Research Organization providing Data Management, Statistical Programming, Biostatistics to Pharma, Biotechnology and Medical Device Industries worldwide and a part of Margasoft company.
Having many years of experience processing