Your challenge
Responsibility:
• Monitoring of external and internal clinical performance evaluations and internal clinical trials (development studies, post-marketing complaints/observations)
• Preparation of relevant documents for clinical trials according to project requirments and internal processes
• "Preparation of study documents (e.g. templates/protocols)
• "Review of study documents (e.g. templates/protocols)
• Performance of site initiations, on-site monitoring, monitoring GBO-lab, remote monitoring and close-out visits
• Communication with investigators, opinion leaders, consultants, CRO, suppliers
• Filing of documents, TMF maintainance
• Training of study team members in accordance with protocol specific requirements and (local) regulations
• Support the (international) trials submission to authorities and ethics committees
• Ensuring the accuracy, validity and completeness of study data
• Trial sites feasibilities
Your Profile
Job Requirements:
• University degree in biology, medicine, pharmacy or an equivalent combination of education, training and work experience in clinical trials
• At least 2 years of experience as a clinical research associate/ clinical monitor in a CRO/medical device or pharmaceutical company
• Good knowledge of current industry practices related to the conduct of clinical trials (ICH-GCP, ISO14155, ISO 20916)
• Good knowledge of MDR and IVDR, as well as good understanding of GDPR
• Experience with FDA, ISO regulations and CLSI guidelines an advantage
• Ability to work independently and reliably in a fast-paced and changing environment
• Excellent communication skills are a must
• Travelling required
• Driving license
We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants - regardless of identifying characteristics such as gender, age, background, social status, veteran status, sexual orientation, religion, or mental and physical abilities. We have additionally set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.
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