Trial Management Specialist

2 days ago


Odense, Odense Kommune, Denmark Syneos Health, Inc. Full time

Clinical Operations Manager Job Description:

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This role will oversee clinical operations for multiple studies, ensuring timely and quality delivery of clinical trial management services. The ideal candidate will have previous experience in clinical trials, with a strong understanding of Good Clinical Practice (GCP) and regulatory requirements.

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Responsibilities:

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  • Manage site interactions, ensuring compliance with GCP, ICH Guidelines and regulatory requirements.
  • Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan.
  • Coordinate initial and ongoing training for the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines.

Qualifications:

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  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
  • Minimum 2 years of experience in clinical trials, with a strong understanding of GCP and regulatory requirements.
  • Excellent communication, presentation and interpersonal skills, with ability to work effectively with cross-functional teams.


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