Key Facts

Remote From:

Fixed term

Mid-level (2-5 years)

English

Hard Skills

Clinical Monitoring Pharmacovigilance Protocol Analysis Educational Planning Regulatory Compliance Protocol Analysis Clinical Data Analysis Vital Signs Regulatory Compliance Active Safety +9 more

Other Skills

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People Management
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Microsoft Office
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Teamwork
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Training And Development
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Critical Thinking
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Verbal Communication Skills

Roles & Responsibilities

Medical degree (MD/DO or international equivalent) with fluent English (oral and written).
5-7 years of work experience in the life sciences industry or related field.
Minimum 4 years of experience with medical monitoring services and strong knowledge of ICH GCP.
Proficiency in Microsoft Office; experience with safety databases (ARISg, Oracle Argus) and/or EDC systems (IBM, Medrio, Medidata) is a plus.

Requirements:

Act as a primary or backup Medical Monitor for assigned clinical studies.
Oversee multiple studies and contribute to regulatory submissions (INDs, etc.).
Provide medical/therapeutic training to the study team and medical expertise to investigators; advise on medical questions.
Lead medical review, assessment, and interpretation of clinical and safety data; escalate critical safety concerns to the study team and Sponsor, and coordinate between sites and study team/Sponsor.

Biorasi

About Biorasi

For over 20 years, Biorasi has been to go-to CRO (Contract Research Organization) for small to midsized biopharma companies, optimizing speed-to-market solutions across global clinical trials in oncology, neurology, dermatology, and cell and gene therapy. Our #OneTeam of leaders and clinical study experts focus on the qualities necessary to succeed in today’s clinical trial industry – flexibility, reliability, and transparency. It is Biorasi’s mission to be a catalyst for growth, innovation, and evolution in the field of clinical research – moving the industry forward while improving results for our partners and outcomes for their patients. Our culture is based on our strong commitment to building true partnerships with our sponsors. We approach all of our trials with urgency, commitment, and resolve. Biorasi is able to directly support studies in the Americas, Europe, and APAC. We have received multiple accolades including placement in the INC 500 and 5000 list of fastest-growing companies in America, Frost and Sullivan’s Entrepreneurial Company of the Year for the CRO Industry, and the CRO Leadership Award from Life Science Leader magazine.

Founded: 2018

Company size: 201 - 500

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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.

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 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.
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 careers@biorasi.com.

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.

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