Senior Project Manager - Canada Remote

As a Sr. Project Manager you will be joining the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Responsibilities:

• Will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy.
• Accountable for the development of realistic detailed study startup and monitoring plans
• 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.)
• 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
• Leads inspection readiness activities related to study management and site readiness
• Approves & oversees drug supply management – manages flow of drug supply to the sites & set up Interactive Voice Randomization System with Supply Chain Lead
• Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs)
• Accountable for the delivery of the study against approved plans
• Reviews consolidated Pre-trial assessment reports, feasibility outputs, etc.
• Operational Study Management for 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies
• 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
• May support study level submission readiness
• 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.
• Core member of the Study Team and will represent the CRO on matters of study execution.
• Study Management Oversight
• Leads study risk planning process in context of site and subject
• Coordinates study/protocol training & investigator meetings
• Approves the Study Startup, Study Monitoring & protocol recruitment plans
• Provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution.
• 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
• May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate
• Works with functional lines and directly with CRO line functions to resolve or triage site level issues.

Qualifications:

Education:

• Minimum BS degree

Skills:

• Extensive global clinical trial/study management experience
• Prior Experience Preferred:
• Demonstrated oversight of CROs
• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
• Demonstrated experience in managing Per Subject Costs, vendor & ancillary, and monitoring costs projections & spend
• Demonstrated study management / leadership experience

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.