* Perform site visits and monitor activities in accordance with protocol, GCP / ICH Guidelines, and applicable regulatory requirements, from SIV to SCV (phase I-IV)
* Mentor CRAs on monitoring, collaborate on procedures development, and query resolution.
* Review and verify case report forms and other clinical data for completeness and accuracy.
* Generate queries and manage resolutions with site staff.
* Maintain project tracking systems as required.
* Use expertise to identify and resolve complex site issues and deficiencies in documentation, communication, and the need for additional training.
* Identify protocol deviations or major risks to data integrity.
* Provide recommendations regarding site-specific actions.
* Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions.
* IMP supply and control.
* Remote work will be approximately 90% of the time.
* Perform site visits and monitor activities in accordance with protocol, GCP / ICH Guidelines, and applicable regulatory requirements, from SIV to SCV (phase I-IV)
* Mentor CRAs on monitoring, collaborate on procedures development, and query resolution.
* Review and verify case report forms and other clinical data for completeness and accuracy.
* Generate queries and manage resolutions with site staff.
* Maintain project tracking systems as required.
* Use expertise to identify and resolve complex site issues and deficiencies in documentation, communication, and the need for additional training.
* Identify protocol deviations or major risks to data integrity.
* Provide recommendations regarding site-specific actions.
* Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions.
* IMP supply and control.
* Remote work will be approximately 90% of the time.
* Bachelor's degree in Science or equivalent combination of education, training and experience.
* Prior 1 year of clinical monitoring experience (preferably in Oncology).
* Fluency in English.
* Excellent communication, presentation, interpersonal skills, both written and spoken.
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