Job Description

As a Senior Project Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.



En tant que chef de projet senior, vous rejoindrez l'organisation de recherche clinique la plus grande et la plus complete au monde, alimentee par l'intelligence des soins de sante.

What you will be doing:

leads and manages the tactical execution of one or more clinical studies from study startup through database release. provides quality oversight to the Contract Research Organisation (CRO) and of the CRO deliverables related to study execution. 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 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. works with functional lines and directly with CRO line functions to resolve or triage site level issues. will drive decision making and work closely with the Clinical Project Manager to provide input to operational strategy.

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

Operational Study Management for 1 or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies Accountable for the development of realistic detailed study startup and monitoring 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 Leads study risk planning process in context of site and subject Coordinates study/protocol training & investigator meetings Develops and provides key inputs to Clinical Trial Budget (e.g., Per Subject Costs) Accountable for the delivery of the study against approved plans Leads inspection readiness activities related to study management and site readiness May produce or review model Informed Consent Document (ICD) and study/country/site level ICD, as appropriate 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.) Study Management Oversight Approves the Study Startup, Study Monitoring & protocol recruitment plans 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. May support study level submission readiness

Ce que vous ferez

Diriger et gerer l'execution tactique d'une ou plusieurs etudes cliniques, du demarrage de l'etude a la publication de la base de donnees. Assurer la supervision qualite de l'organisme de recherche sous contrat (ORC) et des livrables de l'ORC lies a l'execution de l'etude. Diriger et coordonner l'execution d'un essai clinique, du demarrage de l'etude a la publication de la base de donnees et a la preparation a l'inspection, afin de garantir la livraison ponctuelle de donnees d'etude de qualite. Les responsables d'etudes peuvent egalement contribuer a la compilation des sections des rapports d'etudes cliniques. Encadrer les equipes dans la definition d'objectifs de recrutement realistes et de jalons de livraison, en tant que point de responsabilite unique pour le demarrage detaille de l'etude, les plans de suivi et la livraison conformement aux plans convenus. Membre cle de l'equipe d'etude, representera l'ORC sur les questions d'execution de l'etude. Collaborer avec les lignes fonctionnelles et directement avec les fonctions de l'ORC pour resoudre ou trier les problemes au niveau du site. Piloter la prise de decision et collaborer etroitement avec le chef de projet clinique pour contribuer a la strategie operationnelle.

Responsable de la gestion des etudes et de la supervision de toutes les fonctions de gestion des etudes en interne et au sein des CRO

Gestion operationnelle des etudes pour une ou plusieurs etudes de complexite moderee, generalement responsable de tous les aspects de la gestion des etudes assignees

o Responsable de l'elaboration de plans de demarrage et de suivi d'etudes detailles et realisteso Responsable de la realisation des etudes de faisabilite au niveau national en collaboration avec l'Execution mondiale des essais cliniques et les CRO, de l'examen des resultats de l'evaluation prealable a l'essai, de l'approbation des sites et de l'evaluation des plans d'activation des sites

o Pilotage du processus de planification des risques de l'etude en fonction du site et du sujeto Coordonner la formation a l'etude/au protocole et les reunions des investigateurso Elaboration et fourniture d'informations cles pour le budget de l'essai clinique (par exemple, couts par sujet)o Responsable de la realisation de l'etude par rapport aux plans approuves

Pilotage des activites de preparation a l'inspection liees a la gestion de l'etude et a la preparation du site Peut produire ou reviser un modele de document de consentement eclaire (DCI) et un DCI au niveau de l'etude, du pays ou du site, le cas echeant Peut developper le document de conception de l'etude pour en faire un modele de protocole approuve, tout en integrant les contributions des autres membres de l'equipe (par exemple, (Clinicien, responsable de la pharmacologie clinique, responsable de la chaine d'approvisionnement, statisticien, representant de la recherche sur les resultats, groupe d'essais cliniques, etc.) Supervision de la gestion des etudes Approbation du demarrage de l'etude, du suivi de l'etude et des plans de recrutement pour le protocole

o Approbation et supervision de la gestion de l'approvisionnement en medicaments : gestion des flux d'approvisionnement vers les sites et mise en place d'un systeme de randomisation vocale interactive avec le responsable de la chaine d'approvisionnemento Examen des rapports consolides d'evaluation prealable a l'essai, des resultats de faisabilite, etc.

Soutien eventuel a la preparation de la soumission des etudes

You are:

Relevant operational clinical trial experience

A scientific or technical degree is preferred along with knowledge of clinical trial methodology BA/BS 5+ years of relevant experience MBA/MS/ 3+ years of relevant experience BS/BSc/MS/MSc Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility English is required.

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 & spending

Tu es:

Experience operationnelle pertinente en essais cliniques

Un diplome scientifique ou technique, ainsi qu'une connaissance de la methodologie des essais cliniques, sont preferables.

o Licence/Bachelor (5 ans et plus d'experience pertinente)o MBA/Master (3 ans et plus d'experience pertinente)

o Licence/Bachelor (BSc)/Master (MSc)/Master (MSc)o Connaissance pratique des bonnes pratiques cliniques, des operations cliniques et reglementaires et de l'environnement des pays sous responsabilite.

L'anglais est requis.

Experiences prealables souhaitees :

Experience averee en gestion/direction d'etudes

Supervision averee de CRO

Experience averee en gestion des couts par sujet, des fournisseurs et des services auxiliaires, et en suivi des projections de couts et des depenses

What ICON can offer you:

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.




In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.



Our benefits examples include:Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs Competitive retirement planning offerings to maximise 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


Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits



At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.




https://careers.iconplc.com/reasonable-accommodations



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.