ICON plc

Senior Clinical Scientist – Oncology

ICON plc

full-time

Posted on:

Location Type: Remote

Location: Canada

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Job Level

Senior

About the role

  • May lead or support a study or studies, depending on size/complexity.
  • 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
  • Collaborates with medical writer, participates in governance committee review
  • Reviews/updates informed consent
  • Provides scientific input to SM for data management activities (e.g., EDC, DRP, CRFs)
  • Monitors data issues requiring clinical input
  • Prepares scientific slides, attends and presents protocol information at Investigator Meeting
  • Scientific lead on Clinical Trial Team (CTT)
  • 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

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 2 years pharmaceutical and/or clinical drug development experience as a lead CS required.
  • Medical monitoring experience required
  • Oncology experience required
  • Excellent Excel and PP skills required
  • Excellent written and oral communication skills
  • Ability to travel up to 15% (might include international travel)
  • 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.
Benefits
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical researchtrial designendpoint developmentmedical monitoringdata managementprotocol deviation classificationscientific assessmentclinical specificationspharmaceutical developmentoncology
Soft Skills
leadershipcommunicationcollaborationmentoringorganizational skillspresentation skillsscientific inputproblem-solvingattention to detailteamwork