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Senior clinical project coordinator - regulatory affairs

São José dos Pinhais
beBeeClinicalProjectManager
Projectista
Anunciada dia 17 novembro
Descrição

Job Summary

Clinical Project Managers play a crucial role in ensuring the successful delivery of clinical projects within scope, time, and budget. The ideal candidate will have a strong understanding of regulatory requirements, project management principles, and team leadership skills.


Responsibilities:

* Ensure regulatory compliance and implement cross-functional teams to deliver clinical projects on time, within budget, and with high quality.
* Develop project timelines, manage risks, resources, and milestones, and oversee budget forecasting and burn-rate monitoring.
* Communicate effectively with sponsors, vendors, and stakeholders, translating complex requirements into actionable steps.
* Anticipate issues, develop mitigation strategies, and adapt to regulatory or operational changes.


Requirements:

* 3+ years of experience as a Clinical Project Manager.
* Strong knowledge of regulatory requirements, GxP/GEP, RA/MOH, and protocol interpretation across regions.
* End-to-end project delivery, risk, resource, and milestone management.
* Study plan development, proficient with PM tools, and clear stakeholder communication.
* Risk anticipation, adaptability, and solution-oriented approach.


Working Conditions:

* Remote work arrangement.
* Capacity: 2-3 days per week.
* Duration: 12 months.

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