პროექტების მენეჯერი, კლინიკური კვლევის ასისტენტი, ფარმაცევტი

Project Manager, Clinical Research Assistant, Pharmacist

Mandatory Language Requirement - Native Mandarin Chinese

Native-level proficiency in Standard Mandarin Chinese is required. Candidates must be native Mandarin speakers and able to communicate fluently and confidently in Mandarin. Regional accents are acceptable, provided fluency and effective communication in Standard Mandarin are maintained.

Responsibilities - Project Manager:

• Oversee the planning, coordination, and management of clinical research projects in accordance with ICH-GCP guidelines, Arensia`s Standard Operating Procedures (SOPs), and applicable national and international regulations.
• Serve as the primary point of contact between the sponsor, Arensia`s internal departments, investigators, research sites, and external service providers.
• Monitor project progress, timelines, deliverables, and costs to ensure compliance with contractual requirements.
• Coordinate internal teams and external stakeholders, ensuring the availability of the personnel and resources required for project implementation.
• Oversee the preparation and submission of clinical trial documentation to Ethics Committees and regulatory authorities.
• Coordinate clinical trial documentation management, including preparation, maintenance, and archiving.
• Support the identification of potential research sites, patient recruitment strategies, and investigator meetings.
• Participate in sponsor negotiations, subcontractor management, and business development activities.
• Support audit processes, address audit findings, and oversee the implementation of Corrective and Preventive Actions (CAPA).

Responsibilities - Clinical Trial Assistant:

• Assist the Project Manager in the timely and quality execution of project activities in accordance with the Project Agreement, ICH-GCP guidelines, Arensia`s Standard Operating Procedures (SOPs), and applicable national and international regulations.
• Ensure the confidentiality of relevant information.
• Assist in preparing documentation for Ethics Committees and regulatory authorities, as well as clinical research status reports.
• Assist in organizing pre-study visits, monitoring visits, and investigators` meetings, and support research monitoring activities.
• Provide support during ongoing site audits and participate in the review and development of internal standard documentation, including SOPs, forms, instructions, templates, and archive coordination.

Responsibilities - Pharmacist:

• Ensure proper storage of investigational medicinal products (IMPs) in accordance with product labeling requirements and maintain appropriate storage temperatures in medicine storage rooms and pharmaceutical refrigerators.
• Manage IMP inventory, including ordering, replacement, and control of IMP-related materials.
• Ensure the distribution and dispensing of IMPs in accordance with the procedures specified in the clinical trial protocol, and maintain accurate IMP records and documentation.
• Prepare intravenous products for use in accordance with the relevant instructions.
• Maintain cleanliness and order in the clinical trial workplace and communicate with relevant institutions and agencies, when necessary, to resolve medicine-related issues.

Interested applicants should send their Curriculum Vitae via e-mail to the address: salome.chapidze@arensia-em.com.