Medical Device Clinical Study Manager

6 days ago

Cork, Cork, Ireland beBeeClinicalResearch Full time €60,000 - €80,000

Job Title: Clinical Research Associate

Overview:

  • Create and execute comprehensive clinical research projects ensuring adherence to protocols, regulations, and quality standards.

Responsibilities:

  • Collaborate with cross-functional teams in designing, planning, executing, and closing pre-market and post-market clinical studies.
  • Develop and validate study-specific documents, tools, presentations, and processes to ensure compliance and efficiency.
  • Maintain accurate and up-to-date Trial Master Files and Investigator Site Files for multiple studies.
  • Present findings at Investigator meetings and contribute to the development of project reports.
  • Participate in site qualification, study initiation, and study closure process to ensure timely completion and quality deliverables.
  • Manage medical device tracking and accountability to maintain regulatory compliance.
  • Analyze and interpret study data, create databases, and review data/CRFs for integrity, accuracy, and protocol compliance.
  • Track and report progress of studies to stakeholders, providing regular updates on project status.
  • Compile and present study reports and provide clinical insights for regulatory submissions.
  • Conduct monitoring and site visits, preparing detailed reports on site visit, data query, adverse event, and study deviation.
  • Serve as a liaison to work effectively with clinical sites, CROs, SMOs, and vendors/consultants to achieve project objectives.
  • Stay current with regulatory requirements and relevant clinical literature to ensure expertise in the field.
  • Maintain compliance with ISO 13485, ISO 14155, ICH GCP, EU MDR, US 21CFR820, Declaration of Helsinki, Data Protection Act, and other applicable clinical study/trial regulations.

Requirements:

  • Bachelor's degree in Science or related disciplines with a minimum of 4 years of experience in the medical device industry.
  • Proven track record of managing complex projects in pre-market and post-market clinical studies of medical devices.
  • Clinical certifications highly desirable.
  • In-depth understanding of ISO 13485, ISO 14155, ICH GCP, US 21CFR820, and EU MDR.
  • Excellent problem-solving and communication skills with ability to manage multiple priorities and deadlines.
  • Able to thrive in a fast-paced environment and collaborate effectively within an interdisciplinary team.
  • Familiarity with project management methodologies and tools essential.
  • Self-motivated, highly organized, and detail-oriented with excellent written and verbal communication skills.
  • Able to work independently and as part of a cross-functional team to achieve shared goals.

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