Medical Monitor - 0.5 FTE

As a Medical Director you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Understand medical monitoring requirements for assigned projects.
• Develop and review medical monitoring plans and other study related plans.
• Ensure the clinical integrity of the trial subjects and address safety issues during the conduct of the study.
• Act as the main medical resource to support the investigators and sites and study team members.
• Answer eligibility, protocol and safety related questions including routine and urgent queries.
• Maintain current knowledge and overall awareness in the primary field of interest, clinical development in general, and the assigned therapeutic area.
• Work closely with the Pharmacovigilance team providing causality, expectedness assessment and medical input into SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs).
• Review key study documents.
• Perform eligibility/pre-enrolment reviews to evaluate eligibility.
• Perform review of Lab alerts on a day-to-day basis.
• Review coding of Adverse Events, Medical History and Concomitant Medications.
• Support independent committees i.e. Data Safety Monitoring Boards (DSMB), Adjudication committees etc., as needed.
• Perform reviews of Listings of adverse events, medical history, lab data, concomitant medications, physical exams, vital signs, SAEs, AESIs, during the conduct of the study to check for any safety trends or signals, potential safety threats or risks.
• Review cumulative Adverse Event (AE) listings to check if reported AEs are in line with expected safety profile of study drug.

You are:

• MD with advanced clinical training
• Minimum 3 years’ experience in the pharmaceutical industry or related field. Prior Medical Monitoring experience in CRO preferred.
• Demonstrated ability to work collaboratively across all levels of the organization and to lead influentially. Strong interpersonal and negotiation skills.
• Analytical and problem-solving skills; detailed oriented, an independent and critical thinker.
• Excellent communication skills and written, verbal and presentation skills.
• Experience in late stage (phase 2 and 3) clinical trials.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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