Clinical Trial Manager
2 months ago
We are seeking a highly motivated individual to join our team as a Clinical Trial Manager (CTM) to maintain and co-ordinate the logistical aspects of clinical trials in compliance with Good Clinic Practice (GCP) and relevant Standard Operating Procedures (SOPs). The individual is an integral member of the study team who will facilitate operational efficiencies in clinical trials, guided by SOPs and ICH-GCP.
Prior to joining, your experience will have been from a clinical research organization, hospital or large medical specialty clinic, or work at another biopharma. You will be familiar with clinical data and clinical trial terminology, be able to read standard medical abbreviations that are used in the world of medical practice and clinical studies. You will have familiarity with FDA regulations, GCP, essential study documents, and key study activities such as; tracking patient screening and enrollment, clinical laboratory sample collection, regulatory documents, and study team communications. Problem solving skills will be used daily. And did we mention - being highly organized is essential.
Essential Duties and Responsibilities:
Desired Skills & Experience:
Bachelor’s Degree required, relevant scientific or health-care related discipline highly preferred Minimum of 4-6 years of clinical trial management experience, including protocol development, selection and management of CROs and contract vendors, timeline management, and budget management. Prior experience working in the biopharmaceutical industry is desired Thorough understanding and ability to lead a cross-functional team through all activities in the full clinical study life cycle Demonstrated proficiency in management of multi-center international clinical trials (from initiation to closure) Experience managing outsourced work Excellent interpersonal, communication (written and verbal), time management, presentation and organizational skills Management or mentorship experience desired Ability and willingness to travel 5-10% of the time (international and domestic) Notice: JavaScript is required for this content.-
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