Job Description

Our mid-sized medical device client is adding a Clinical Study Manager to the team! The Clinical Study Manager will report to the Director of Clinical and oversee clinical activities related to one or more clinical studies, and performing/managing the daily in-house operations associated with the studies. The Clinical Study Manager will work independently on multiple complex clinical studies using critical thinking skills. Will be managing one study in start-up and another ongoing study. The new study will have about 70 patients and 5 centers.

Your role with the company:

• Responsible for managing clinical studies in accordance with internal standard operating procedures and applicable regulations and guidelines
• Collaborate with internal and external clinical team members and consultants to draft clinical study protocols, Instructions for Use, Report of Prior Investigations, Investigational Brochures, and other clinical study documentation
• Oversee clinical site selection and activation
• Manage study safety by tracking and reporting adverse events as required by regulatory bodies, reviewing adverse event trends, and overseeing safety committees including Clinical Events Committees and Data Safety Monitoring Boards
• Oversee monitoring activities related to assigned clinical studies, including review and approval of monitoring plan and monitoring reports, managing monitoring schedule and ensuring corrective action related to monitoring findings
• Develop training plans for study training and review/approve training documentation
• Prepare study-related reports including annual, interim and final study reports
• Organize and lead study-related conference calls and Investigator meetings as needed through the study
• Oversee investigational device allocation, distribution and reconciliation
• Collaborate with data management team to ensure appropriate data capture and query management
• Assist with and/or perform data analysis
• Use critical thinking skills to review and analyze scientific journal articles
• Assist with generation and/or review of study-related abstracts, posters, presentations, manuscripts as needed

Desired Profile:

• Bachelor’s Degree (science preferred as well as Masters)
• Ability to travel 20 - 30% (US and international travel required)
• Previous clinical research experience (minimum 5 years) and clinical study management (minimum 2 years) required
• International clinical experience preferred
• Previous collaboration with physician investigators
• Strong knowledge of clinical research study design and study monitoring functions
• Understanding of GCP and 21 CFR 812
• Experience working with Institutional Review Boards and/or Ethics Committees
• Strong technical writing skills

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