Job Description

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, and we are unlike any CRO you’ve ever heard of.
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.
Start your career journey at Biorasi today with our newest opportunity- Senior Medical Monitor! This is a remote based position located anywhere within India.
Overview

• We are international: Our headquarters is in Aventura, Florida. Other locations are Germany, India, Russia, and Ukraine.
• Our work culture includes: teamwork, hands-on mentality, flexibility, and open communication.
• Development and worklife balance: We want our employees to develop personally as well as professionally.

Your Responsibilities

• Act as a study Primary Medical Monitor for the assigned clinical studies.
• Be a Medical expert and readily available to investigator, site, and study team to advise on medical related questions.
• Provide Sites with the knowledge to properly evaluate subjects and adhere to the protocol.
• Responsible for providing protocol training to the study team, as needed.
• 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.
• Prepare case studies and lead the DMC meetings and Sponsor calls.
• Work closely with Safety and Pharmacovigilance team to provide medical input into safety reports including, SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, and Company Core Safety Information (CCSI), etc.
• 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.
• Assist in the design and conduct of clinical trials including the development of first draft and review of protocols and amendments.
• Follow international GCP guidelines/regulations and SOPs for executing clinical studies.
• Lead in developing and maintaining SOPs, Templates, and study plans
• Assist in Medical Monitoring related Audit activities that may occur.
• Train and mentor new personnel within the branch
• Perform other duties for the Medical & Scientific Affairs branch, as assigned

• Medical degree, MD, DO or its international equivalent.
• 2-5 years’ experience within the pharmaceutical industry or related field
• Must have previous Medical Monitor experience in oncology/neurology. Cell and/or gene therapy is desirable.
• Keen knowledge and thorough understanding of ICH GCP and applicable regulatory requirements.
• Strong written and verbal communication, presentation skills, and professional English language level
• 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.
We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy summer half-day Fridays, paid time off, paid holidays, extensive country specific benefits, employee bonus programs, career growth, training and development.
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.