• Working on all relevant SOPs/Policies of conducting clinical trials/BE studies• Conducting training on all procedures for the conduct of the study• Overseeing the smooth running of clinical trials/BA studies• In charge of document management• Managing research budgets• Informing participants about study objectives• Monitoring research participants to ensure adherence to study rules.• Adhering to research regulatory standards and ethical standards.• Engaging with subjects and understanding their concerns• Communication with Primary Investigator and Sub-Investigators• Maintaining research records of study activity, including case report forms, drug dispensation records or other regulatory forms as per FDA guidelines• Full support in preparation of IRB submission packages• Full involvement in both regulatory and external/client based audits

• Define the Company QMS objectives, assist in QMS risk assessment and strategic direction jointly with Company management;• Promote and effectively manage the development, implementation, and enhancement of integrated QMS, ISMS and PIMS in line with the requirements of ISO 9001:2015, ISO 27001:2013 and 27701:2019, respectively;• Assist Technical QA in validation process for EDC or related software solutions • Manage Quality Assurance department activities;• Participate in the periodic SOP review process with SMEs according to regulatory requirements• Oversee the Company’s QMS activities, including establishment and continual improvement of the QMS processes;• Manage the Deviation/CAPA system• Supervise and facilitate both internal and external audits• Conduct QMS vendor/supplier assessments, etc

• Develop, implement, maintain, and communicate the corporate quality strategy, quality annual plan and quality programs throughout the Company• Design and integrate an effective, necessary and adequate Quality Management System, incorporating relevant SOPs and/or any other documents• Responsible for CAPA/Deviation Management • Coordinate activities and lead interactions during regulatory agency inspections• Provide feedback to operational department heads regarding audits, plans, findings, CAPAs, and issue resolution• Perform and administer external audits according to a predefined audit plan.• Prepare audit report and perform follow-up audit• Ensure that all deviations/non-conformances are reported and corrective and preventive actions implemented in a timely manner

• Prepare and direct the technical aspects of managing the company in accordance with GxP guidelines• Development/review/implementation of the Quality Management system/SOPs• Ensure compliance to protocols, SOPs and regulatory requirements• Conduct of the GCP investigator sites audits• Conduct an audit for each bioequivalence study• Conduct of the TMF/vendors’ audits• Propose effective and efficient CAPA and noncompliance management, • Daily team quality consulting and support• Quality Improvement activities (lesson learned sessions, trainings, changes in regulations regarding GCP and QA, for clinical staff• Make corrections on identified problems, deficiencies, potential problems or suspicions• Check of statistical compliance • Periodically submit to the management reports on each study• Clinical report check (submission to FDA)

• Plan and sustain the M&E systems to provide quality information • Ensure proper and timely implementation of M&E activities• Document good practice from planning, implementation, monitoring and evaluation of activities.• Support Proposal development and Reporting• Develop and adapt strategic plans & proposals to ensure the mission’s objectives are achieved, integrating innovative approaches to M&E activities• Report writing both in quarterly and annual bases both for the management and donors• Working as a team while designing and implementation of monitoring systems• In contact with TB patients and their satisfactory assessments on their treatment• Designing and statistical analyses of research’s findings

• Carry out company strategy, under the direction of the Director• Prepare, edit and oversee the preparation of the tender proposals• Maintain contacts with Armenian, US and European suppliers• Draft and solicit content for tender proposals, quotations, etc.• Respond to requests and refer them to the Director, as necessary• Conduct e-mail and other correspondence with suppliers and clients on behalf of the Company• Consult the staff on chemicals, reagents, laboratory consumables• To plan and conduct product search and to gather other related information, as needed• Plan and execute events, including meetings, conferences, etc.• Prepare the list and meet with potential local customers to increase the clientele base

• Planning and carrying out trials• Tracking environmental microorganism development• Growing microbe cultures• Collecting samples from a variety of locations• Recording, analyzing and interpreting data• Ensuring that data is recorded accurately in accordance to guidelines• Observing high health and safety standards