QA Manager/ Clinical Project Manager (CRO)
Вакансия № 26570538 в населенном пункте (городе) Москва, Россия от компании "MDCE??????????????" на сайте Электронный Центр Занятости Населения (ЦЗН) Москвы.
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Обязательное требование к опыту работы искомого сотрудника: более 6 лет.
График работы: полный день.
Тип занятости: полная занятость.
Вакансия № 26570538 добавлена в базу данных: Суббота, 6 сентября 2025 года.
Дата обновления этого объявления: Суббота, 27 сентября 2025 года.
| Рейтинг вакансии: 16,04 из 100 баллов |
Работодатель может предложить примерно следующую оплату труда: от 4500 до 5000 USD на вакантной должности "QA Manager/ Clinical Project Manager (CRO)".
- We can accept
Part-time/Remote Full-time/Relocation Full-time (Relocate to China after the probation and we'll be responsible for the work Visa and relocation)
The Position of QAM
- Your responsibilities will include:
- Revise MDCE’s Quality Management System, including revision of SOPs, processes, etc
- Preparing, conducting, and reporting of QA study audits, internal systems and location audits, vendor qualification audits and maintain relevant communication with the auditee;
- Communicating with project teams with regard to QA study audits, including follow-up and resolution;
- Engage you into Audit projects for our sponsors;
- Assembling QA audits documentation;
- Training MDCE Operations staff in quality management topics.
- Qualifications
- MD, PharmD or degree in life sciences is a plus;
- A minimum of 5 years’ experience in quality management or quality assurance;
- Must have experience in planning, conducting and reporting of QA audits;
- Excellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulations;
- Team oriented with superior communication and interpersonal skills including a proactive attitude to tasks and projects;
- Excellent time management skills;
- Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment;
- Full working proficiency in English;
- Proficiency in MS Office applications;
- Ability to travel.
The Position of CPM
- Summary:
Planning, executing and reporting on a number of phase I-IV and device clinical studies in the region, from planning and site feasibility through study close-out, in compliance with MDCE SOPs and regulatory requirements. Coordinating and managing the activities of individual studies and staff in a manner that ensures all timeframes and targets are met and that costs are kept under control. Effective management of assigned staff to ensure high performance, continuous development and low turnover.
- Job Responsibilities
- Recognise, exemplify and adhere to MDCE’s values which centre around our commitment to People, Clients and Performance
- Manage projects in a timely manner in adherence with MDCE SOPs, ICH GCP and appropriate regulations and liaise with other department managers as necessary to achieve this.
- Develop and maintain a detailed project plan.
- Manage projects in accordance with the contract. Proactively recognise any changes in scope and collaborate with Business Development (BD) to ensure timely completion of change orders.
- Effectively manage the study budget to ensure financial targets are met through regular review of indirect costs and project resources. Collaborate with Finance to ensure accurate revenue recognition.
- Implement QC procedures and monitor quality metrics to ensure a high-quality standard is maintained throughout the project.
- Act as the key client contact for designated projects and develop successful working relationships with clients.
- Ensure all necessary training is provided to assigned staff to improve their job performance and knowledge. Provide coaching/mentoring, as necessary. Implement individual development plans and ensure training is documented, as appropriate.
- Effectively manage staff through open and timely sharing of information, regular performance review and feedback, and setting clear goals and objectives. Ensure individual and team achievements are appropriately recognized.
- Develop a succession plan and, in the event of a change to the team, ensure a thorough and effective handover which is appropriately documented.
- Ensure time management system is up to date and monitor workload for assigned Clinical Research Associates. Proactively flag potential resource issues to Director, Project Management.
- Provide regular feedback to senior management on project status, client satisfaction and staff issues.
- Participate in interviews, as required.
- Liaise with other managers to improve the effectiveness of the organization.
- Maintain confidentiality of management information, as appropriate.
- Ability and willingness to travel at least 35% of the time (international and domestic; fly and drive).
- Participate in business development activities, as appropriate.
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