Start up georgia

Join our team as a Start-up Associate in Georgia.

Start-up Associate is responsible for biomedical research start within a targeted country start-up timelines and client satisfaction, good quality of submission dossiers, and good communication with EC and CA and investigators.

Responsibilities:

• Participate (provide SSU feedback) in the evaluation and selection of qualified investigators and sites for clinical trial conduct
• Confirm submission strategy and timelines for the initial study submission/approval and amendments submission/approval during the study duration. Keep initially agreed timelines
• Prepare and submit required clinical trial applications, reports, and other documentation to applicable Authorities (CA/LEC) for initial clinical trial approval and amendments approval, notifications submission during the study duration
• Prepare submission documents and share with the site for LEC submission
• Follow up with the site and ensure that submission is done and approval is received
• Coordinate communication with applicable Authorities and respond to their queries
• Prepare clinical trial documents and maintain correspondence and files, store and archive them
• Track changes in the legal framework regulating all aspects of the conduct of biomedicinal research and update about the changes
• Support CRA in preparation and negotiation of clinical trial agreements with investigators and institutions
• Collect/support CRA with the collection of the site essential documents required for IP release approval and compile the IP pack of good quality which corresponds to local regulations to initiate the study in the specific country
• Collaborate on other projects related to the company activities

Requirements:

• University degree in Life Science field (Medicine, Pharmacy and etc.)
• Fluent English language
• 2 year’s experience in Clinical Research field and at least 1 year experience in CA/LEC submissions in Georgia
• Good knowledge of local biomedical trial regulatory requirements and ICH-GCP
• Time management and problem-solving skills
• Ability to work independently and in a team

Benefits of being a part of our team:

• Professional growth and career opportunities
• Supportive work environment
• Additional benefits (bonus system, additional health insurance and etc.)
• International team

 

Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials, Regulatory Affairs, Pharmacovigilance and Medical Information. With headquarters in Lithuania and offices in Switzerland, Russia, Georgia, Ukraine, Poland, Kazakhstan and Sweden, Biomapas operations are spread over 5 continents, concentrated in Europe, Russia and former CIS region.

 

Job Category: Clinical Research
Job Type: Full Time
Job Location: Georgia

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