Clinical Research Project Manager

4 days ago

Bucharest, Romania beBeeResearch Full time

Responsibilities include managing clinical site monitoring services for projects of varying complexity. In this in-house role, you will oversee the design and implementation of project monitoring services, including training, site recruitment, data/document management, budget oversight, and regulatory compliance.

Monitoring Expertise
  • You will act as a subject matter expert, mentor, coach, and/or provide performance feedback to colleagues.
  • Assist with the selection, hiring, training, and supervision of clinical research associates (CRAs) as needed. Perform co-monitoring and training visits with CRAs.
  • Act as the primary point of contact for resolving site/patient issues or addressing sponsor concerns.
  • Represent the organization by maintaining collaborative relationships with stakeholders.
Project Lead
  • Manage monitoring services for a group of projects and/or CRAs on large/complex projects, directing/guiding day-to-day activities and reviewing/approving monitoring reports.
  • Function as liaison between CRAs and other functional teams, escalating concerns and issues to management as needed.
  • Participate in and present at study team, kickoff, and investigator meetings, acting as the primary contact for sponsors on all monitoring-related issues.
Site Recruitment and Setup
  • Identify and recruit site investigators, coordinate trial material delivery, and ensure SOPs are in place to optimize patient recruitment.
  • Provide guidance to site teams on inclusion/exclusion criteria.
Investigational Site Monitoring
  • Serve as the primary clinical site contact.
  • Facilitate and support site staff with access to study systems, ensuring sites are compliant with project-specific training requirements.
  • Ensure all site-related issues are addressed until resolution.
  • Coordinate delivery of clinical site communications, collaborating with project teams to ensure investigational sites receive accurate ongoing data, updates, information, and feedback on project/regulatory guidelines and objectives throughout the project lifecycle.
Qualifications
  • The ideal candidate possesses a minimum of a college diploma/degree and 4-6 years of related experience.
  • Self-motivation, strong communication skills, and a commitment to achieving positive results are essential.
  • A keen attention to detail, ability to engage in continuous learning, and a commitment to fostering teamwork are necessary skills.

This is a home-based role with regular travel required.

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