Job Description

Project Manager (Study Start Up) - Canada

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.

The Start Up Project Manager (SUPM) is responsible for defining, developing and delivering the global study start up project strategy by partnering with roles across GSSO, CD&O, Global Regulatory Submissions and others as required. The SUPM will be assigned to one or more interventional studies in one or more therapy areas such as oncology, vaccines, internal medicine, rare disease or inflammation and immunology. The responsibility of the SUPM typically ends when all investigative sites are activated and ready to enroll participants, however this can extend further into the participant recruitment period to specifically deliver the implementation of protocol amendments across active sites for selected studies. The SUPM will have a comprehensive knowledge of managing and coordinating study start up activities globally.

The SUPM I will typically take full responsibility for small to medium size studies located in a single country or region, or for selected countries or region(s) within a larger global study where another SUPM is responsible for the site activations of the entire study. The SUPM is the leader of the start up team for the study, region(s) or countries assigned.

What You Will Do:

• TheSUPMisresponsiblefordeliveringsiteactivationstoplan,fortheSUPMIthiscanbeforallsitesforan entire study or a portion of sites in specific countries in one or more regions.

• As part of the responsibility of delivering site activations to plan the SUPM will co-ordinate with many differentrolesworkingatthestudyandcountryleveltooverseeprogressofthestudyspecific(e.g.Vendor set-up, investigational product supply etc.) or country specific tasks (e.g. Regulatory submissions, importer of record for supplies etc.) that need to be completed in order for site activations in turn to complete.

• Provideprojectmanagementofactivitiesdirectlyrequiredtocompleteallsiteactivationsforanassigned studyas part of a study management led team to complete all start up activities for a study.

• Lead start up meetings that facilitate alignment of site selection to activation activities performed by country level start up roles with the endorsed trial optimization plan (by senior leadership).Start up meetingsusetheongoingriskassessmentofsiteactivationdeliverytoformafocusedagendaaccordingto risk level, the overall goal is the delivery of major study milestones to plan (e.g. first subject first visit) as wellastheoveralldeliveryofmajorsiteactivationstoplan(25%,50%and90%ofplannedsiteactivations)

• TheSUPMwillworkwithcountrylevelstartuprolestoseekopportunitiestoacceleratesiteactivationsfor their study, they will do so while considering therelative priority of their study compared to all concurrent studies in start up that country level start up roles are working on.

• Act as a key point of escalations for site activation related issues raised by country level start up roles, seekingtofirstlyresolveissuesdirectlyortriageappropriatelytootherSUPMsonthestudyorthestudy management team, will always follow through to resolution.

• Responsible for the completeness and quality of site activation timeline plans for every site from investigatorinitiationpackagesentforfirstsiteinstudy,tositeactivationcompleteforlastsiteinstudy. Willworkwithanddrivealltimelineplanowners(e.g.countrystartuproles)toactivelymanagethesite activation timeline plans for their assigned sites.The SUPM will have a detailed understanding of the timeline for every site:

• Understandingthecriticalpathactivitiesforallsitesbasedonspecificneedsofeverysiteandtheir associated upstream country and study related tasks

• Plan and execute the timely delivery of the investigator initiation package needed for investigationalproductreleasetositeinpartnershipwithdocumentowners(particularcountry level roles), including incorporating the translation requirements into that plan.

• Workinlockstepwithspecialistrolesthatworkdirectlywithsitesonthestudybudgetsand contracts to bring this key activity off the site activation critical path

• Co-ordinateacrossallrolesthatworkdirectlywithsitestafftocompletesiteactivationreadiness tasks (system access and training, protocol related training) to time completion prior to the site initiation visit,or as soon as possible afterwards to reduce or eliminate from the site activation critical path

• Work across roles responsible for the delivery of all physical supplies (investigational product and all non-clinical supplies) to plan and execute delivery to all sites in lock step with all other tasks required for site activation

• Identify improvements and efficiencies to site activation processes and share lessons learned broadly with key stakeholders

Your Profile:

• Extensive global start up clinical trial/study management experience

• Comprehensive working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations

• A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology

• BS/BA – 5 years relevant experience

• MS/PhD – 3 years relevant experience

• FluencyinEnglishisrequired

• Demonstrated start up experience

• Demonstrated project management experience

• Country or Regional start up exposure/experience in the countries under responsibility across at least two major therapeutic areas

• Technical expertise in use of software (off the shelf and custom) for the management of clinical studies with prowess in using reporting systems (dashboards and associated basic data analysis) to comprehend and communicate status

• Ability to use basic generative artificial intelligence techniques in daily work

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