от компании (организации): Parexel International в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Клинические исследования"
с заработной платой: по договоренности
Вакансия № 5025669 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Суббота, 17 августа 2024 года.
Дата обновления вакансии № 5025669 на сайте Работа в Москве и Московской области (МО, Подмосковье): Пятница, 27 сентября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 5025669 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
3–6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Inititation Clinical Site Manager
Where available an “Initiation Clinical Site Manager“(iCSM) specializing in Pre SIV activities will be
assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study.
The iCSM can also support protocol amendments if applicable.
Study Phase Accountability & Supporting Activities may include but not limited to the following:
- Start-Up(from site identification through preinitiation)
- Act as PAREXEL’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Build relationships with investigators and site staff.
- Conduct, drive and manage country specific feasibility and/or site prequalification and qualification activities, which may include:
- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
- Conduct remote Qualification Visits (QVs).
- Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
- Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
- Forecast, develop, manage, and revise plans and strategies for:
- IRB/IEC and MoH / RA submission/approval
- Site activation
- Patient recruitment & retention.
- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
- Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity,
- study non-compliance, etc.
- Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.
- Actively participate in Investigator and other external or internal meetings, audits & regulatory inspections.
- Work in a self-driven capacity, with limited need for oversight.
- Proactively keep manager informed about work progress and any issues.
Skills:
- Sound problem solving skills.
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Advance presentation skills.
- Client focused approach to work.
- Ability to interact professionally within a client organization.
- Flexible attitude with respect to work assignments and new learning.
- Ability to prioritize multiple tasks, and achieve project timelines; utilizing strong analytical skills to
- make decision autonomously due to the unpredictable nature of the issues that arise.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management
- System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
- Strong interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
- Effective time management in order to meet study needs, team objectives, and department goals.
- Developing ability to work across cultures.
- Shows commitment to and performs consistently high quality work.
- Ability to successfully work in a (‘virtual’) team environment.
- Consulting Skills
- Able to accommodate travel time requirements, according to tasks allocation/phase of the study
- assigned.
- Attention to detail.
- Holds a driver’s license where required
Knowledge and Experience:
- Site Management experience or equivalent experience in clinical research, with understanding of
- clinical trials methodology and terminology
Education:
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
Apply now to begin your journey!
Откликнуться на эту вакансию: Inititation Clinical Site Manager
Предыдущая вакансия:
Вакансия № 5025644 на должность Менеджер по закупкам от компании ЕВРОПЕЙСКИЙ МЕДИЦИНСКИЙ ЦЕНТР в городе (населенном пункте) Москва