Senior Clinical Study Manager

📋 Description

• Accountable for leading assigned clinical research activities
• Partner with internal stakeholders, investigators and KOLs to develop and review study design and
• Accountable for the planning and execution of the clinical studies including site selection, review
• Accountable for autonomously conducting clinical studies on schedule and within budget while
• Perform on-site and remote site qualification visits, site initiation visits, interim monitoring
• Conduct clinical study monitoring to ensure regulatory and protocol compliance as well as overall

🎯 Requirements

• Previous experience implementing, helping and managing medical device trials Significant knowledge
• Proven experience in protocol and ICF development, writing clinical section(s) for regulatory
• Proven experience in conducting literature searches, reviews and appraisal of the scientific data
• Excellent ability to interact with physicians and other professionals inside and outside the company
• Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge
• Experience negotiating clinical research contracts and budgets

🎁 Benefits

• Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity
• Equal Opportunity Employer
• Reasonable accommodations for qualified individuals with disabilities