Clinical Monitor

4 weeks ago

Dublin, Dublin City, Ireland Life Science Recruitment Full time
Clinical Monitor

Our client, a pharmaceutical company based in Dublin, is currently recruiting for a Clinical Monitor to join their growing team on a permanent basis. As Clinical Monitor, you will collaborate with the Clinical Project Manager to oversee and ensure the compliance and quality of clinical trials. This role requires extensive travel (at least 50% of the time) to the clinical sites distributed in different EU and non-EU countries, ensuring adherence to protocols, regulatory requirements, and company standards. Experience monitoring clinical trials in the therapeutic area of Gastrointestinal (GI) diseases and/or Oncology is highly desirable.

Responsibilities:

  • Conduct on-site visits or co-monitoring visits with the study monitors appointed by the CRO managing the study, to monitor compliance with study protocols, Good Clinical Practice (GCP), and regulatory guidelines.
  • Perform on-site visits at clinical sites as Sponsor's representative to maintain Investigators' engagement in the clinical trials they are participating in.
  • Whenever necessary, train and support investigators and site staff on study protocols and procedures.
  • Identify and resolve site-related issues to ensure the integrity of clinical data.
  • Collaborate with cross-functional teams to ensure seamless trial execution.
  • Assist with the selection and qualification of study sites.
  • Ensure adherence to ethical guidelines and patient safety requirements.
  • Maintain communication with site personnel, investigators, and internal teams.

Requirements:

  • Bachelor's or Master's degree in Life Sciences, Pharmacy, or a related field.
  • Minimum of 3-5 years of experience in clinical monitoring within the pharmaceutical industry or CROs.
  • Strong knowledge of clinical trial regulations (FDA, EMA, ICH-GCP).
  • Proven experience in conducting site visits and monitoring international clinical trials.
  • Excellent organizational, communication, and problem-solving skills.
  • Ability to work independently and manage multiple priorities.
  • Willingness to travel at least 50% of the time.
  • Proficiency in EDC system and other relevant software.
  • European Citizen with driving licence.

For more information please contact Sinéad Cullen at +353879500821 or sinead.cullen@lifescience.ie.

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