Medical Monitor/Clinical Scientist

Medical Monitor opportunities with one of the largest and most reputable global Clinical Research Organizations in ICON.

Sponsor Aligned Medical Monitor Responsibilities:

• Scientific lead on Clinical Trial Team (CTT)
• Co- authors newsletters with SM
• Coordinates planning of lab, bio specimens and imaging specifications
• Participates in Database lock activities Collaboratively plans CSRs, CTDs/WMAs with medical writing
• Authors protocol clarification letters
• Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system
• Contributor to study specific documents (e.g., SMP)
• Responsible for trial design and endpoint development in collaboration with CD
• Provides scientific assessment for Operational Reviews
• Supports SM/MW activities as needed to achieve CTT deliverables.
• Monitors central lab reports and other external data for safety and critical values
• Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports
• Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites)
• May act as mentor to other CSs
• Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)
• Collaborates with medical writing to develop trial results communication for investigators
• Sets up/supports SAC, DMC, adjudication committees
• Reviews/updates informed consent
• Assesses and prepares protocol deviation list for CSR
• Lead or support a study or studies, depending on size/complexity. Accountable for the clinical/scientific execution of the protocol.
• Protocols/amendments – collaborates with medical writer, participates in governance committee review
• As lead, will be responsible for the following:
• Monitors data issues requiring clinical input
• Prepares scientific slides, attends and presents protocol information at Investigator Meeting
• Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO)
• Supports publications/presentations as needed
• Reconciles and review all protocol deviation classifications in SPECTRUM

Educational Requirements

• MS/PhD in Life Sciences with 5+ years clinical research experience
• If no degree in Life Sciences, must have significant experience in clinical development (>11 years)
• BS/BA in Life Sciences with 7+ yrs clinical research experience

Minimum Years of Experience

• Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead CS required.
• Excellent Excel and PP skills required
• Excellent written and oral communication skills
• To qualify, applicants must be legally authorized to work in the Canada or US, and should not require, now or in the future, sponsorship for employment visa status
• Ability to travel up to 15% (might include international travel)
• Medical monitoring experience required
• Oncology experience required