Role Description
Provide medical data review support to ICON Project Teams in order to ensure that projects of all phases (1-4) are conducted according to the highest ethical principles and medical standards, in accordance with good pharmacovigilance practices and in compliance with applicable legal and regulatory standards.
Provide medical leadership on projects, when assigned.
Job Functions/Responsibilities:
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Serve as medical team leader on assigned projects.
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Ensure provision of all contracted activities and identification of out of scope activities on projects assigned.
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Medical review of clinical trial data, including:
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Review of Laboratory alerts
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Electrocardiogram (ECG) alerts
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Data from eCRF/EDC (listing review/Patient profile review)
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Eligibility review
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Identify protocol deviations
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Coding review
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Preparation of Medical Monitoring Reports as per requirement
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Provide all necessary medical support functions as defined by project specific contractual obligations, which will include, but not be limited to:
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Medical information source
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Ongoing training for project teams in therapeutic areas as requested
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Review of study documentation (protocol, CRF, etc.)
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Contribute to investigator meeting presentations
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Ongoing safety review of individual patient laboratory reports generated by central laboratories
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CRF safety review
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Contribute any necessary medical input into integrated clinical and statistical reports
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Assist in making presentations to potential clients when appropriate
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Demonstrate a thorough understanding of ICON Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs.
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Demonstrate a thorough understanding of applicable regulatory standards in the country where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations.
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Represent ICON Medical Affairs at teleconferences and meetings.
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Liaise with Sponsors regarding medical issues and medical consultation.
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Ensure quality of medical deliverables in accordance with project plans and ICON Standards.
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Keep the person to whom the Clinical Research Physician reports informed of any issues within the department which require attention.
Qualifications
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Medical degree and broad-based post graduate clinical experience.
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Preferably 1-2 yearsβ experience in a relevant role, ability to medically evaluate clinical data, and good analytical skills.
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Proficiency in English, good oral and written communication skills.
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Ability and willingness to travel on an as-need basis.
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Excellent presentation skills.
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Good computer skills (MS: Outlook, Word, Excel).
Requirements
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To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
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The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Benefits
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Very competitive salary packages.
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Annual bonuses reflecting delivery of performance goals.
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A range of health-related benefits to employees and their families.
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Competitive retirement plans and related benefits such as life assurance.
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Environment encouraging fulfillment of sense of purpose and drive lasting change.
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Various annual leave entitlements.
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A range of health insurance offerings to suit you and your familyβs needs.
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Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals.
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Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.