Medical Director – Contract

This is a fully remote position, open to applicants in Florida.

📋 Description

• Contribute strategic insights into existing and prospective clinical projects

• Assist site investigators

• Oversee medical monitoring and all medical facets of clinical trials

• Offer strategic guidance for proposal development and bid-defense discussions

• Aid in data evaluation and medical writing for protocols and study-specific reports, including regulatory annual reports and clinical study reports

• Facilitate FDA interactions, encompassing IND and IDE support alongside related meetings

• Review and resolve queries from sites and CRAs regarding inclusion/exclusion criteria

• Compile listings of protocol deviations and adverse events for regular meetings

• Conduct initial reviews for coding and reconcile coding based on input from clinical and medical teams

• Formulate strategies for FDA submissions

• Develop protocols

• Draft appropriate study plans

• Support medical monitoring in the management of clinical trials

⛳️ Requirements

• MD or PhD in Gastroenterology & Hepatology or a related field

• Valid MD or PhD license

• Minimum of 2 years' experience in clinical trials as a medical monitoring associate or equivalent relevant experience

• Experience in Gastroenterology and Hepatology

• Excellent communication skills

• Proficiency in medical writing

• Capability to work independently

• Proficient in Excel

• Familiarity with CTMS

• Willingness to work in shifts as required

🏝️ Benefits

• Variable pay

• Paid time off

• Healthcare benefits

• Retirement benefits

• Competitive salary