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Clinical Trial Monitor

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29 NOV ’21: For a world renowned Pharmaceutical organisation with a focus on oncology, hematology, immunology and cardiovascular disease we are currently recruiting for a Clinical Trial Monitor. Prompted by promising developments in their pipeline this Clinical Trial Monitor is greatly welcomed. Are you an ambitious clinical professional who wishes to help drive these promising developments forward all the while challenging and improving yourself, then please continue reading below!

  • Pharmaceutical
  • Clinical Research
  • Utrecht
  • 40 hours p/week
Get to know

Your consultant

About your role

This is how you will make the difference

As a Clinical Trial Monitor you will be responsible for the oversight of clinical trial progress and ensuring the proper conduct, recording, and reporting (i.e. GCP, SOP and regulatory requirements). You will be a point of contact for internal stakeholders at site level and main point of contact at country level for external stakeholders.

To be more specific, you will:

  • Identify new potential investigators, through ongoing collaborations with internal and external stakeholders
  • Assess potential investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials
  • Develop site relationships (incl. Contract Research Organisation related issue management and non-registrational /Investigator Sponsored Research Studies)
  • Recommend sites during the site feasibility and/or site selection process
  • Conduct pre-study visits as appropriate
  • Conduct initiation visits to ensure investigator and site personnel receives adequate protocol specific training prior to site activation
  • Review site activities and quality through on-site and off-site visits
  • Conduct monitoring activities and ensure safety and protection of study subjects as per the monitoring plan, procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable
  • Perform unblinded site monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor
  • Demonstrate the ability to use data to assess risks while monitoring, identify issues and make appropriate decisions
  • Serve as a point of contact for sites
  • Provide trainings to sites
  • Perform site closure activities when all required protocol visits and follow-up are completed
  • Manage multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory
  • Ensure completeness and quality of data submitted from study sites
  • Ensure eCRF data is available and up-to-date by using the available systems to follow site activities
  • Oversee activities of site personnel over whom there is no direct authority
  • Motivate/influence the site to meet study objectives, including enrolment and retention goals
  • Demonstrate flexibility and adaptability when communicating with different stakeholders, utilising the most appropriate communication method
  • Anticipate, identify and proactively support site in resolving issues as they occur
  • Appropriately document and promptly escalate serious or persistent outstanding issues to management and project team. Initiate, recommend, document and communicate corrective actions as needed and follow up to ensure corrective/preventive actions based on root cause analysis are implemented
  • Be involved in regulatory compliance audit/inspection process, as needed (this includes the development and implementation of site corrective and preventive actions)
  • Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner

Please note that the above responsibilities may be supplemented by additional tasks when needed.

What's needed

What you bring

As the ideal candidate for this challenging role you have:

  • A Bachelors or Masters degree in Life Science (or related) study
  • A minimum of two to five years relevant clinical research experience
  • Good working knowledge of ICH/GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials
  • Knowledge and understanding of clinical research processes, regulations and methodology
  • Understanding of clinical landscape with practical knowledge of a variety of medical settings and medical records management
  • Organisation and time management skills and the ability to work independently
  • The ability to build, maintain and strengthen relationships even under pressure and/or in difficult situations
  • Good verbal and written communication skills (both in English and Dutch)

What we offer

What's in it for you

To reward you for your efforts in executing this role to the utmost best of your abilities and helping the organisation attain its goals, the following will be offered:

  • A competitive base salary
  • An additional bonus at an interesting percentage
  • LTI eligibility
  • Health insurance plus life and accident insurance
  • A solid pension plan
  • Thirty vacation days
  • A company car
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