Senior, Medical Monitor (Contract)

We are Growing ! Let us support your career journey the Biorasi way.  Innovative, Collaborative, Dynamic and Evolving.  Capitalizing on your strengths while encouraging work-life balance.  Biorasi is an award-winning, customer-focused, full-service clinical research organization. Biorasi is looking for top performers who are as passionate about clinical research as we are – clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry. 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 m edical  expert ise  to investigator s  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 classificatio n   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  D efence preparation and meetings.   Responsible for Line Management of assigned team members in Medical and Scientific Affairs group.    Support regulatory inspections and audits as needed.   Perform other duties for the Medical & Scientific Affairs branch, as assigned.   Your Profile: Medical degree, MD, DO or its international equivalent. 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 Keen knowledge and understanding of ICH GCP 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 (IBM, Medrio, Medidata) a plus 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 [email protected] . Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.