Sr. Clinical Project Manager - Canada Remote

As a Senior Study Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:

• Will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans.
• Leads and coordinates the execution of a clinical trial from Study start-up through Database release and inspection readiness to ensure timely delivery of quality study data. Study Managers may also input to and support compilation of sections to Clinical Study Reports
• Provides quality oversight to the Contract Research Organisation (CRO) and of the CRO deliverables related to study execution.
• Works with functional lines and directly with CRO line functions to resolve or triage site level issues.
• Core member of the Study Team and will represent the CRO on matters of study execution.
• Will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy.
• Leads and manages the tactical execution of one or more clinical studies from study startup through database release.

Responsible for Study Management and oversight of all Study Management functions internally and at the CROs

• Leads inspection readiness activities related to study management and site readiness
• May expand study design document into approved protocol template while incorporating input from other team members (e.g., Clinician, Clinical Pharmacology Lead, Supply Chain Lead, Statistician, Outcomes Research Representative, Clinical Assay Group, etc.)
• Coordinates study/protocol training & investigator meetings
• Approves the Study Startup, Study Monitoring & protocol recruitment plans
• Accountable for conducting country level feasibility in collaboration with Global Clinical Trial Execution and CROs, reviewing Pre-trial Assessment outputs , approving sites, and assessing site activation plans
• Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
• May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
• May support study level submission readiness
• Leads study risk planning process in context of site and subject
• Approves & oversees drug supply management – manages flow of drug supply to the sites & set up Interactive Voice Randomisation System with Supply Chain Lead
• Reviews consolidated Pre-trial assessment reports, feasibility outputs, etc.
• Accountable for the delivery of the study against approved plans
• Accountable for the development of realistic detailed study startup and monitoring plans
• Study Management Oversight
• Operational Study Management for 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies

You are:
Education:
Minimum BS degree
Skills:
Extensive global clinical trial/study management experience
Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
Prior Experience Preferred:
Demonstrated study management / leadership experience
Demonstrated oversight of CROs
Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend
Why ICON?
Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.