Senior Clinical Scientist

Job description

Senior Clinical Scientist - Infectious Disease (HIV) ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. What you will be doing: May lead or support a study or studies, depending on size/complexity. If lead, accountable for the clinical/scientific execution of the protocol. As lead, will be responsible for the following: Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g., IRB, sites) Responsible for trial design and endpoint development in collaboration with CD Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports Sets up/supports SAC, DMC, adjudication committees Protocols/amendments – collaborates with medical writer, participates in governance committee review Authors protocol clarification letters Contributor to study specific documents (e.g., SMP) Reviews/updates informed consent Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs) Monitors data issues requiring clinical input Monitors central lab reports and other external data for safety and critical values Prepares scientific slides, attends and presents protocol information at Investigator Meeting Scientific lead on Clinical Trial Team (CTT) Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system Coordinates planning of lab, bio specimens and imaging specifications Co- authors newsletters with SM Participates in Database lock activities Collaboratively plans CSRs, CTDs/WMAs with medical writing Supports publications/presentations as needed Reconciles and review all protocol deviation classifications in SPECTRUM Assesses and prepares protocol deviation list for CSR Collaborates with medical writing to develop trial results communication for investigators Provides scientific assessment for Operational Reviews Supports SM/MW activities as needed to achieve CTT deliverables. Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO) May act as mentor to other CSs What you need to have: Educational Requirements BS/BA in Life Sciences with 7+ yrs clinical research experience 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) Minimum Years of Experience Minimum 2 years pharmaceutical and/or clinical drug development experience as a lead CS required. Medical monitoring experience required Infectious Disease experience required. HIV experience highly preferred. Excellent Excel and PP skills required Excellent written and oral communication skills Ability to travel up to 15% (might include international travel) 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 Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: Competitive base salary and performance related incentives Health and wellbeing programmes including medical, dental, and vision coverage where applicable Retirement and pension plans Life assurance and disability coverage Employee assistance programmes and wellbeing resources Learning and development opportunities through structured training and career pathways Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here . Are you a current ICON Employee? Please click here to apply