Site Activation Specialist/Специалист по активации центров в рамках клин исследований, Казахстан at MCT CRO — NeverHard

Site Activation Specialist Required Qualifications: BS/BA degree or Associates degree with ≥2 years of experience in the health care field or direct clinical trial related experience. Must have knowledge of clinical trial conduct General knowledge of drug development and ICH/GCP guidelines Requires proven project management skills Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability. Fluent in English. Minimal (0-5%) travel required Preferred Qualifications: N/A Roles and Responsibilities: Support the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives Generate and provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools Proactively identify and escalate issues that arise related to support SSU deliverables Effectively execute against assigned activities within SSU Support implementation of standards for global SSU team This may include: Oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements Implementation of the SSU Strategy for assigned region during the study start up period Building relationships with internal counterparts and site staff to support successful site activation strategies Projecting site activation timelines and appropriately escalating when things get off track Adhering to process and tools designed to the support of the SSU team with day-to-day activities Leading the preparation of study level essential document templates Aiding in the preparation of content for Regulatory submissions Handling ICF negotiations and facilitating any required escalations Preparation and submission of IMP Release Packages Maintaining accurate and timely information in relevant clinical systems Responsible for complying with regulations and guidelines and ensuring adherence in support of assigned clinical trials. This position has no direct reports but may provide guidance/oversight to contract staff. Специалист по активации центров Квалификационные требования: Степень бакалавра/специалиста (BS/BA) или младшего специалиста (Associate) + минимум 2 года опыта в здравоохранении или клинических испытаниях. Обязательное знание правил проведения клинических испытаний, основ разработки лекарств и руководств ICH/GCP. Обязанности: Поддержка повседневных операций отдела запуска исследований (SSU) для своевременного выполнения целей в соответствии с GCP/ICH и нормативами. Ведение актуальной информации по статусу проектов в системах отслеживания. Выявление и эскалация проблем, влияющих на результаты SSU. Содействие внедрению глобальных стандартов SSU. В рамках этой роли: Контроль активации центров (от получения списка до открытия): сбор документов, переговоры по информированному согласию (ICF), подача в IRB/EC, выпуск препарата (IMP). Реализация стратегии SSU в закрепленном регионе. Прогнозирование сроков активации и эскалация отклонений. Подготовка шаблонов основных документов и материалов для регуляторных органов. Ведение точных данных в клинических системах. Соблюдение нормативных требований. Руководство подчиненными не предусмотрено, возможно курирование внештатного персонала. Навыки управления проектами, отличные коммуникативные и административные навыки, владение ПК. Свободный английский язык. Командировки: 0–5%.