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Senior Project Manager - Clinical Trials
Отличная вакансия для опытных менеджеров: работа в специализированной CRO с фокусом на передовую науку, возможность удаленной работы и участие в жизненно важных разработках. Высокий балл за четкие требования и профессиональную среду.
Сложность вакансии
Высокая сложность обусловлена требованием глубокой экспертизы в онкологии и минимум 4-летнего опыта управления полносервисными (full-service) клиническими исследованиями именно в CRO. Роль подразумевает полную ответственность за бюджет, сроки и управление кросс-функциональными командами на глобальном уровне.
Анализ зарплаты
Предлагаемая позиция Senior Project Manager в Венгрии соответствует европейским стандартам для CRO. Указанный диапазон отражает рыночные ставки для специалистов с опытом 5-7 лет в клинических исследованиях в регионе Центральной Европы.
Сопроводительное письмо
I am writing to express my strong interest in the Senior Project Manager position at Precision for Medicine. With over [Number] years of experience in clinical project management within the CRO industry, specifically focusing on complex Oncology trials, I have developed a deep understanding of the full-service oversight required to deliver successful global studies. My background aligns perfectly with your need for a leader who can manage cross-functional teams, oversee budgets, and maintain high-level client relationships from proposal to completion.
Throughout my career, I have successfully navigated the challenges of Phase I-IV trials, ensuring compliance with GCP/ICH guidelines while meeting rigorous timelines and quality standards. I am particularly drawn to Precision for Medicine’s integrated approach to biomarker-driven research and your commitment to oncology and rare diseases. I am confident that my consultative approach to trial management and my dedication to improving patient outcomes will make me a valuable asset to your global team.
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Описание вакансии
Are you an experienced full service Project Manager in the field of clinical trials who’s engaged in addressing the challenges facing the research and development of novel compounds in Oncology. Are you passionate about impacting the health and lives of patients around the world? Do you take a consultative approach to trial management, proving to be a valuable partner in trial operational delivery?
Precision for Medicine are looking to hire a (Senior) Project Manager ideally with experience in Oncology who have managed full service clinical trials within a CRO setting to join our global team.
In this pivotal role you will have full service oversight for clinical projects across global/regional (ph I-IV) trials, within Oncology (or Rare Diseases or CNS). Accountable for clinical project delivery, oversight of all functional departments, and ensuring agreed timelines, scope, cost and quality.
Involved in all study stages, including proposal strategy, development, costing, and bid defence, and seeing studies through the full cycle to completion, managing the client relationship, project team and budget and timelines throughout.
You will work in a cross-functional team with both internal and external stakeholders, driving quality and coordinating the study team.
We offer an amazing high-energy, dedicated, collaborative team members who enjoy a challenge, thrive in the details and flourish in dynamic environments. If you are no stranger to taking charge and seek positive teamwork to deliver extraordinary work, we have an opportunity for you.
How we will keep you busy and support your growth:
- You will independently lead clinical projects in accordance with the study budget and scope of work. You will use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives. You may be called upon to run international trials as well.
- Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations
- Liaise with Project Team and senior management of both Precision and sponsors, including C level
- Handle and lead all aspects of a clinical research trial or trials
- Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc.
- Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation.
- Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials
- Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets
Requirements:
- Degree or similar related life science qualification, or equivalent combination of education and experience.
- Previous experience in a full service/global Project Management role working in the CRO industry is essential.
- 5 to 7 years industry experience and at least 4 years full service Project Management experience in a clinical trial setting working for a Clinical Research Organisation.
- Experience managing studies within Oncology
- Working understanding of GCP/ICH guidelines and the clinical development process
- Ability to drive and availability for domestic and international travel including overnight stays
- Be able to communicate effectively in the English language both written and spoken
- Strong presentation skills
- Proven computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS)
- Proven ability to develop positive working relationships with individual and teams internally and externally
- Demonstrated core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan
Precision for Medicine's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology.
We are a people focussed CRO with a supportive and collaborative environment which promotes work life balance and encourages team development.
We invite you to learn more about our growing organization serving our clients that are researching ground-breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day.
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
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Навыки
- Project Management
- Clinical Trials
- Oncology
- CRO
- GCP
- ICH Guidelines
- CTMS
- eTMF
- EDC
- IXRS
- Microsoft Project
- PowerPoint
Возможные вопросы на собеседовании
Проверка специфического опыта в онкологии, который является ключевым для этой роли.
Расскажите о наиболее сложном онкологическом проекте, которым вы управляли: с какими специфическими проблемами набора пациентов или протокола вы столкнулись?
Оценка навыков финансового управления и контроля бюджета в рамках CRO.
Как вы подходите к управлению бюджетом исследования и предотвращению выхода за рамки утвержденной сметы (out-of-scope)?
Проверка опыта взаимодействия с высшим руководством заказчика.
Опишите ваш опыт участия в защите заявок (bid defense) и взаимодействия с C-level представителями спонсоров.
Оценка лидерских качеств в матричной структуре.
Как вы координируете работу различных функциональных отделов (Data Management, Safety, Biostatistics), если возникают конфликтующие приоритеты?
Проверка знаний регуляторных стандартов.
Как вы обеспечиваете соблюдение стандартов GCP и качества данных при управлении международными исследованиями с участием нескольких регионов?
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