от компании (организации): АстраЗенека в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Клинические исследования"
с заработной платой: по договоренности
Вакансия № 21948950 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Вторник, 22 октября 2024 года.
Дата обновления вакансии № 21948950 на сайте Работа в Москве и Московской области (МО, Подмосковье): Четверг, 14 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 21948950 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
1–3 года
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Local Study Manager
Responsibilities:
- Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
- Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.
- Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
- Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with ADSMM/CH).
- Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
- Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
- Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
- Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
- Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
- Reviews monitoring visit reports (as required and following AZ SOPs) and pro-actively advices the monitor(s) on study related matters.
- Proactively identifies risks and facilitates resolution of complex study problems and issues.
- Organises regular Local Study Team meetings on an agenda driven basis.
- Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
- Reports study progress/update to the Global Study Leader/ Global Study Team including SMM Lead.
- Plans and leads National Investigator meetings, in line with local codes, as required.
- Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
- Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level.
- Ensures accurate payments related to the study are performed according to local regulations and agreements.
Requirements: - Bachelors degree in related discipline, preferably in life science, or equivalent qualification.
- Minimum 3 years of experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies).
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
- Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
Откликнуться на эту вакансию: Local Study Manager
Предыдущая вакансия:
Вакансия № 21948946 на должность Главный бухгалтер/ведущий бухгалтер от компании ООО Евроазиатский Финансовый Дом в городе (населенном пункте) Москва