
Clinical Trial Operations Specialist
Há 10 horas
We are seeking an experienced Clinical Trial Operations Specialist to join our team. As a Clinical Trial Operations Specialist, you will be responsible for the local management of clinical trials in countries around the world.
This role is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities.
You will lead and coordinate local trial team activities in compliance with Standard Operating Procedures (SOPs), other procedural documents, and applicable regulations.
Your responsibilities will include:
- Collaborating with Functional Managers and Clinical Research Managers for country protocol feasibility and site feasibility assessment
- Implementing local criteria for site selection and ensuring consistent conduct of Site Qualification Visits
- Contributing input to study management documents at a country level
- Leading and coordinating local trial team activities
- Maintaining and updating trial management systems
- Analyzing trial progress using study tools and management reports
To be successful in this role, you will need a minimum of 2 years of clinical trial management experience or a total of at least 5 years of clinical trial monitoring and/or clinical trial management experience.
You should have a good understanding of the drug development process including GCP and local regulatory requirements.
The ideal candidate will be able to work independently and as part of a team, and will have excellent communication and problem-solving skills.
In return, we offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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