Project manager in clinical research

Clarenta; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Clarenta приглашает опытного менеджера проекта в области клинических исследований. Вы будете вести проекты от инициации до завершения, координировать задачи между функциональными командами и обеспечивать соответствие TMF и протоколам.

Требуется не менее 4 лет опыта, знание ICH-GCP и навыков взаимодействия с клиентами. Вакансия предполагает работу в международной CRO среде и возможность совершенствовать профессиональные компетенции.

Qualifications

• Высшее образование в области медицины/биомедицинских наук.
• Опыт управления клиническими испытаниями не менее 4 лет.
• Понимание процесса клинических исследований и вовлечённых функций.
• Знание ICH-GCP и регуляторных требований страны.
• Отличные организационные навыки и умение работать с несколькими командами.

Responsibilities

• Управление клиническими проектами от инициации до завершения и документирование.
• Содействие в процессах контрактования совместно с внутренними командами.
• Координация feasibilty, распределение ресурсов и跨-функциональное взаимодействие.
• Разработка и поддержка плана проекта и документов (TMF, протокол отклонения, обучение).
• Контроль и сообщение статуса проекта клиентам и внутренним командам.

Skills

Клиническое управление проектами

Управление заинтересованными сторонами

Планирование и организация

Презентационные навыки

Адаптивность

Education

Бакалавр/Магистр в медико-биологических науках

Tools

CTMS

EDC

eTMF

Job description

Описание

Clarenta is a European full-service Contract Research Organization (CRO), with a dedicated Phase I Unit based in Sofia, Bulgaria. We provide comprehensive clinical research services to pharmaceutical and biotechnology companies across international markets, supporting the development of innovative treatments and contributing to the advancement of global healthcare. As we continue to grow, we are looking for an experienced, organized, and proactive Project Manager

Задачи

• Manage clinical research projects from initiation through completion, ensuring all relevant information is collected and documented.
• Support the contracting process in collaboration with the appropriate internal teams.
• Coordinate project feasibility activities, resource allocation, and cross-functional collaboration.
• Develop and maintain project management plans and related documentation, including communication, risk management, Trial Master File (TMF), protocol deviation, and training plans.
• Oversee clinical trial submission and approval processes with Ethics Committees (ECs) and Regulatory Authorities (RAs).
• Define project-specific performance metrics in agreement with the client, as required.
• Organize and lead internal and client kick-off meetings.
• Coordinate the translation of project-specific documentation when necessary.
• Conduct project risk assessments and develop appropriate mitigation strategies.
• Act as the primary point of contact for clients when assigned.
• Delegate tasks and responsibilities to the appropriate team members.
• Support the practical training and mentoring of new team members, as needed.
• Track project milestones, deliverables, timelines, and contractual obligations, ensuring accurate and timely reporting.
• Ensure consistent project organization and execution in accordance with established procedures and quality standards.
• Provide regular project status updates to clients and internal operational teams.
• Organize and oversee project-specific training activities.
• Manage project-related issues, including identification, escalation, follow-up, and resolution.
• Facilitate effective communication and collaboration among all project stakeholders.
• Oversee study-related logistics and operational procedures.
• Ensure proper project closure, including completion of required documentation, lessons learned, and Sponsor feedback.
• Support the Quality team in preparing for project-specific audits, as required.
• Perform additional responsibilities as assigned by the Senior Project Manager (SPM) or Group Head of Project Management (GHPM).
• Contribute to marketing activities, client presentations, and proposal development.
• Participate in professional and industry meetings as a representative of Clarenta.

Требования

• Graduate or postgraduate degrees in medical sciences, healthcare, pharmacy, or another relevant field.
• At least 4 years of experience in clinical trial project management.
• Thorough understanding of the clinical research process and the functional areas involved in clinical trial management.
• Working knowledge of current ICH-GCP guidelines and applicable country-specific regulations.
• Strong organizational, communication, and interpersonal skills, with the ability to adapt to changing priorities.
• Excellent presentation and stakeholder management skills.
• Strong problem-solving, decision-making, analytical, and issue-resolution abilities.
• A positive, collaborative attitude and a high degree of professionalism and confidentiality.
• Ability to work effectively in a multicultural environment and coordinate teams across different locations and time zones.
• Ability to understand the interdependencies between business needs, operational activities, and functional requirements.
• Proficiency in MS Office, particularly Word, Excel, and PowerPoint.
• Familiarity with eClinical systems, including CTMS, EDC, and eTMF.

Условия

At Clarenta, your work contributes to something bigger. Join an international CRO environment where scientific innovation meets collaboration, and where your expertise helps bring clinical research forward. Work alongside talented professionals from diverse disciplines, engage with global clients, and play a key role in delivering clinical trials that drive medical progress and make a real difference in patients’ lives. At Clarenta, you’ll have the opportunity to grow professionally while contributing to research that truly matters.