Director, Clinical Safety & Medical Monitoring CRO

Role Overview

The Director, Clinical Safety & Medical Monitoring CRO will lead the Safety team and promote operational excellence by monitoring and improving processes related to management of Individual Safety Case Reports of Adverse Events / Serious Adverse Events (ICSRs), Clinical Events Committees (CECs), and Data Monitoring Committees (DMCs).

What You Will Do

The Director will develop and/or maintain knowledge of current Good Clinical Practices, Good Vigilance Practices, Safety best writing practices, and data entry conventions. They will also act as a leader and mentor to Safety team members and non-Safety staff, and maintain qualified staff by recruiting, selecting, orienting, and training Associates.

Why It Might Be a Fit

The ideal candidate will have a strong interest in Science, Mathematics, and Healthcare, and will be able to work independently with strong organizational skills and attention to detail. They will also have a high degree of personal and professional integrity, and will be willing to travel as necessary for conferences and client meetings.

Requirements

• Doctor of Medicine degree and postgraduate training from an accredited institution
• At least 5 years of relevant experience
• Current medical license preferred
• Strong leadership and communication skills
• Must be able to work independently
• Strong organizational skills with attention to detail
• Familiarity with GCP, ICH and FDA requirements as applicable for Clinical Data Science
• Demonstrate a high degree of personal and professional integrity
• Willingness to travel as necessary for conferences and client meetings
• Knowledge of and experience with Microsoft Word, Excel and other medical writing tools
• Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases

Benefits

• Dental insurance
• Vision insurance
• Health insurance
• 401(k) or retirement plan
• Paid time off (vacation, sick leave, etc.)
• Life insurance
• Disability insurance
• Flexible spending account (FSA)
• Health savings account (HSA)
• Employee assistance program (EAP)
• Wellness programs
• Professional development opportunities
• Equity or stock options
• Bonus or commission structure
• Paid holidays
• Annual salary range of $152,300.00 – $296,600.00