Senior Medical Monitor, Contractor

Your role:

• Act as a primary or backup Medical Monitor for the assigned clinical studies. 
• Oversee multiple studies, contribute to the regulatory submissions (INDs, etc.) 
• Responsible for providing protocol/therapeutic training to the study team, as required. 
• Provide medical expertise to investigators and study team and advise on medical related questions.  
• Perform eligibility review of the study subjects, as required. 
• Lead in medical review, assessment, and interpretation of clinical and safety data to ensure that the data are correct and presented with the appropriate medical interpretation. Escalate any critical safety concerns to the study team and Sponsor, and coordinate between sites and study team/Sponsor.  
• Responsible for identifying, reviewing and confirming protocol deviation classification 
• Lead the Medical Monitoring and Protocol deviation project meetings, participate in any other Sponsor calls, if required. 
• Work closely with Safety and Pharmacovigilance team to provide medical input into safety reports including, SAE narratives and analysis of similar events, periodic safety reports.  
• Responsible for the review of individual data with SAEs and potentially clinically important laboratory test results or vital sign abnormalities and escalate issues to the Sponsor as needed.   
• Assist in medical and scientific review of deliverables such as TLFs and CSR.  
• Lead in developing and maintaining SOPs, Templates, and study plans 
• Participate in the review of the design and conduct of clinical trials including the development and review of protocols and amendments.  
• Assist in incorporating medical strategy into study feasibility required for new projects. 
• Cooperate with program development and commercial teams to develop the medical strategy for the RFP for new projects. 
• Participate and lead medical strategy section in the Bid Defence preparation and meetings. 
• Responsible for Line Management of assigned team members in Medical and Scientific Affairs group.  
• Support regulatory inspections and audits as needed.

Your Profile:

• Medical degree, MD or its international equivalent.
• Active medical license 
• Fluent English (oral and written).  
• Proven 5-7 years’ work experience within the life science industry or related field 
• Minimum 4 years’ experience with medical monitoring services 
• Strong understanding of GCP/ICH guidelines and applicable regulatory requirements 
• Excellent verbal, written communication and presentation skills. 
• Critical Thinking and background medical and scientific research  
• Strong Proficiency in using Microsoft Office 
• Experience with safety databases (ARISg, Oracle Argus, etc.) and/or EDC system (Zelta, Medrio, Oracle Clinical, Medidata)  

If you have the experience required and want to join an energetic, creative, and collaborative team, please apply directly to our website at https://biorasi.com or email us at careers@biorasi.com.