Clinical Trial Manager

Job Description:

NoyMed CRO is looking for a Clinical Trial Manager to join our dynamic and fast-growing team.

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

Requirements:

• 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