Clinical Research Project Manager

Artivion Careers-posted 11 days ago
Full-time • Mid Level
Kennesaw, GA
1,001-5,000 employees
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To support the successful execution of global clinical trials by ensuring regulatory compliance, managing site and vendor activities, maintaining data integrity, and contributing to high-quality clinical documentation. This role advances the development of innovative surgical implants for complex heart disease while collaborating cross-functionally and upholding international standards for patient safety and study quality.

  • Supports regulatory submissions to competent authorities.
  • May act as a site manager, and may provide site training.
  • Interacts with sites in accordance with local law, standards, and regulations.
  • Participates in vendor selection process.
  • Works with vendor on contracts.
  • Manages invoices.
  • Collaborates on core clinical documents.
  • Represents the core clinical documents and study processes to participating sites in the context of Site Regulatory Binders.
  • Executes/supports clinical investigators with preparation and submission of required documentation to Institutional Review Boards (IRBs)/Ethics Committee (EC) for approval.
  • Ensures maintenance of IRB/EC approval throughout the duration of the study.
  • Provides training to clinical investigators and study personnel regarding protocol requirements, data collection and reporting requirements as necessary.
  • Assists with developing Health Care Provider (HCP) presentations.
  • May engage with cross functional teams.
  • Facilitates queries for all missing or inaccurate data.
  • Ensures that data changes are properly implemented and captured in the database or data system.
  • Assists in the evaluation and analysis of clinical trial data.
  • Disseminates publications to sites as necessary.
  • Review clinical reports and conduct quality and consistency checks for regulatory submission and/or scientific publication.
  • Learn the function and clinical applications of a surgical implant which treats complex heart disease conditions, understand the indication, safety, and performance objectives and parameters and ensure consistency across multiple clinical documents.
  • Contribute to EU Medical Device Regulation processes and documentation generation and support submissions to Notified Bodies.
  • Support ongoing Post-Market Surveillance and Quality Assurance activities
  • Ability to travel domestically and internationally up to 30% of the time.
  • Bachelor’s degree in biological science, engineering, or another science-related field
  • Minimum 2 years’ experience planning and executing clinical research studies [or] relevant experience, or advanced degree with 1 years’ experience
  • Experience overseeing multicenter investigational (e.g. IDE/ pre-CE) studies
  • Demonstrate project management, critical thinking, and communication skills
  • Proficient knowledge of medical terminology.
  • Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications
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