Senior Clinical Scientist - Oncology - Home Based

ICON plc • Montreal, QC

20d • Remote

About The Position

At ICON Strategic Solutions, the Senior Clinical Scientist works in a sponsor-dedicated model supported by ICON’s global expertise. The role may lead or support one or more studies, depending on their size and complexity. When leading a study, the role is accountable for the clinical and scientific execution of the protocol and serves as the scientific lead on the Clinical Trial Team (CTT). The position may also mentor other Clinical Scientists and support Study Management and Medical Writing activities to achieve CTT deliverables.

Requirements

• Bachelor’s degree in Life Sciences with at least 7 years of clinical research experience, or a master’s or Ph.D. in Life Sciences with at least 5 years of clinical research experience.
• If the degree is not in Life Sciences, significant clinical-development experience exceeding 11 years is required.
• At least 2 years of pharmaceutical and/or clinical drug-development experience as a lead Clinical Scientist.
• Medical monitoring experience.
• Oncology experience.
• Excellent Excel and PowerPoint skills.
• Excellent written and oral communication skills.
• Ability to travel up to 15%, potentially including international travel.
• Legal authorization to work in Canada or the United States without requiring employment-visa sponsorship now or in the future.

Responsibilities

• Serve as the clinical point of contact for scientific questions and issues raised by internal and external stakeholders, such as IRBs and study sites.
• Lead or support study and protocol execution; when acting as study lead, be accountable for clinical and scientific execution.
• Collaborate with the Clinical Director on trial design and endpoint development.
• Lead the Medical Monitoring team’s activities, including developing the Medical Monitoring Plan and reviewing SAE reports.
• Establish and support safety advisory committees, data monitoring committees, and adjudication committees.
• Collaborate with medical writers on protocols and amendments, and participate in governance committee reviews.
• Author protocol clarification letters and contribute to study-specific documents such as the SMP.
• Review and update informed consent documents.
• Provide scientific input to Study Management for data-management activities, including EDC, DRP, and CRFs; monitor data issues requiring clinical input.
• Monitor central laboratory reports and other external data for safety findings and critical values.
• Prepare scientific slides and attend and present protocol information at Investigator Meetings.
• Review specifications and initiate allocation (randomization) request forms and approval schedules in the allocation schedule generation system.
• Coordinate planning of laboratory, biospecimen, and imaging specifications.
• Co-author newsletters with Study Management.
• Participate in database-lock activities and collaboratively plan CSRs and CTDs/WMAs with Medical Writing.
• Support publications and presentations as needed.
• Reconcile and review protocol-deviation classifications in SPECTRUM; assess and prepare the protocol-deviation list for the CSR.
• Collaborate with Medical Writing to develop trial-results communications for investigators.
• Provide scientific assessments for Operational Reviews.
• Support Study Management and Medical Writing activities as needed to achieve CTT deliverables.
• Provide clinical specifications to Study Management to support interactions with external vendors, such as IVRS and ePRO.
• Mentor other Clinical Scientists, as needed.

Benefits

• Competitive base salary and performance-related incentives.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior