Senior Project Manager, Early Phase and Translational Research (Sr. PM, EPTR) The Senior Project Manager, Early Phase and Translational Research (Sr. PM, EPTR) oversees and manages domestic, regional and/or international projects.

The senior project manager is responsible for developing and managing project teams, communications, risk, scope, schedule, cost, quality, and stakeholders, effectively ensuring that variance from plan is proactively and effectively mitigated and client expectations are met.

The Sr. PM, EPTR is expected to have a working knowledge of drug development and clinical trial execution. S/he has overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials.

The Senior Project Manager acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline).

The Sr. PM, EPTR also acts as a mentor and provides training to other project managers and actively contributes to continuous improvement efforts of the department.

More specifically, the Senior Project Manager, EPTR must: Serves as primary contact for the Sponsor, sites, CRAs, vendors and internal team throughout the study.

Ensures assigned studies are audit ready at all times (project team training records, central files, system validation, etc.).

Communicates effectively with sponsors, study team members, functional departments, and senior management Serve as escalation point for project issues to internal and external stakeholders, as appropriate.

Proactively identify and resolve conflicts.

Proactively, manages operational aspects of the clinical trial including trial timelines, budget, resources and vendors.

Coordinates tasks and deliverables from all functional departments involved in the project.

Controls the project budget by ensuring that project team member understand the hours allocation for each task and review time billed to the study against the budget to control write-off and identify out of scope activities for change orders Provides efficient updates on trial progress to the internal and external stakeholders, with respect to site selection, vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.

Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract Defines and manages project resource needs and establish succession plans for key team members.

Leads study start-up process, including but not limited to conduct of the Trial Kick-off meeting the set-up of trial master file (TMF), site selection and finalization of site lists, site activation, management of vendor set up timelines and site contracting and budgeting.

Manages risk and control measures to assure project quality.

Escalates issue appropriately to Innovaderm management, quality assurance and sponsor, when required.

Leads client calls, internal work groups, vendor status update meetings.

Ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File (TMF) in a timely manner.

Monitors the quality of study deliverables, (including vendor and SubCRO deliverables), addresses quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the study team Analyzes discrepancies between planned and actual results and participates in the development and implementation of corrective actions to be taken as needed.

Ensures that project specific training matrix is customized to each study and maintained accurate through out the study Ensures all team members including contracted services providers have adequate training on the project by reviewing training records periodically during the trial Reviews and approves Indero, site, and vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.

Ensures that study specific documents and project deliverables (e.g., study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report, etc.) are developed on time and meet study requirements Ensures all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures Provides project status updates to external and internal stakeholders ensuring compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements.

Manages and reports on recruitment status and highlights initiatives needed to mitigate slippage in recruitment timelines Participates in the planning and conduct of Investigators Meetings Collaborate with the Regulatory Affairs group, to ensures submission to central are done on time and collection of required essential documents is complete prior to site initiation and maintained current throughout study duration.

Ensures that the Trial Master File (TMF) is complete,



accurate, and inspection ready at all times.

Oversee clinical monitoring activities for site qualification, initiation, routine and close-out visits (i.e. project-specific training of CRAs, reviewing monitoring visit reports and follow-up letters, ensuring compliance with monitoring plan, escalation of site-related issues).

Contributes to the development of the Clinical Monitoring Plan.

Prepares and conducts project-specific training for the CRAs; may perform study initiation visits (SIV) for single-site studies.

Develops the annotated site visit reports and monitoring tools such as source data verification worksheets.

May serve as a point of contact for CRAs and Lead CRAs for assigned projects.

Supports the sites and ensures that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.) In collaboration with the data management group, ensures that the CRF complies with the protocol and Sponsor requirements and ensures queries resolution and data review process follow the study timelines until database lock.

Mentors team members.

In collaboration with relevant departments, prepare and deliver presentations for new business as required May provide technical, therapeutic and project management expertise in training and process improvement efforts for the department Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

Brand name: Indero Our company: The work environment At Indero, you will work with brilliant and driven colleagues.

Our values are collaboration, innovation, reliability, and responsiveness.

We offer a stimulating work environment and attractive advancement opportunities.

Work location Note that this opening is for a home-based position in Canada Regular travel, which may include overnight trips and / or international travel is required as part of this role.

About Indero Indero is a contract research organization (CRO) specialized in dermatology.

Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients.

Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal prospect to all individuals.

As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Canada.

Description de poste: Chef de projet principal Phase prcoce et recherche translationnelle (Sr. PM, EPTR) Le/la Chef de projet principal EPTR supervise et gre des projets cliniques nationaux, rgionaux et/ou internationaux.

Il/elle est responsable de la constitution et de la gestion des quipes projet, des communications, des risques, du primtre, du calendrier, des cots, de la qualit et des parties prenantes.

Il/elle veille ce que les carts par rapport au plan soient anticips et grs efficacement, tout en rpondant aux attentes du client.

Le/la Sr. PM EPTR doit avoir une bonne connaissance du dveloppement de mdicaments et de la conduite des essais cliniques.

Il/elle est responsable de linitiation, de la planification, de lexcution, du suivi, du contrle et de la clture des essais cliniques qui lui sont confis.

Il/elle est le principal point de contact pour les parties prenantes et contribue la faisabilit, la conception de ltude, llaboration du budget et au suivi de lavancement (ressources, budget, dlais).

Il/elle agit galement comme mentor, forme les autres chefs de projet et contribue activement aux efforts damlioration continue du dpartement.

Responsabilits principales Agir comme point de contact principal pour le promoteur, les sites, les ARC, les fournisseurs et lquipe interne.

Veiller ce que les tudes soient toujours prtes pour un audit (formations, fichiers centraux, validation des systmes, etc.).

Communiquer efficacement avec les sponsors, les membres de lquipe, les dpartements fonctionnels et la direction.

Grer les conflits et les problmes du projet de manire proactive.

Superviser les aspects oprationnels : dlais, budget, ressources, fournisseurs.

Contrler le budget du projet et identifier les activits hors primtre.

Fournir des mises jour rgulires sur lavancement de ltude.

Dfinir les indicateurs de performance cls (KPI) et sassurer quils respectent le contrat.

Grer les besoins en ressources et tablir des plans de succession.

Diriger le dmarrage de ltude : runion de lancement, TMF, slection et activation des sites, fournisseurs, contrats.

Grer les risques et assurer la qualit du projet.

Diriger les runions avec les clients, les fournisseurs et les quipes internes.





Surveiller la qualit des livrables et proposer des amliorations.

Analyser les carts et mettre en uvre des actions correctives.

Maintenir jour la matrice de formation spcifique au projet.

Vrifier que tous les membres de lquipe sont correctement forms.

Examiner et approuver les rponses aux audits qualit.

Veiller ce que les documents de ltude soient livrs dans les dlais et conformes.

Superviser le classement et larchivage des documents dans le TMF.

Fournir des mises jour de statut conformes aux SOP, BPC et exigences rglementaires.

Grer le recrutement et proposer des actions pour viter les retards.

Participer lorganisation des runions investigateurs.

Collaborer avec les affaires rglementaires pour les soumissions et la gestion des documents essentiels.

Superviser les activits de monitoring : qualification, initiation, visites de routine et de clture.

Contribuer au plan de monitoring clinique.

Former les ARC et ventuellement raliser des visites dinitiation.

Dvelopper les outils de monitoring (rapports, grilles de vrification).

Servir de point de contact pour les ARC.

Sassurer que les sites disposent du matriel ncessaire.

Collaborer avec la gestion des donnes pour garantir la conformit du CRF et le respect des dlais jusquau verrouillage de la base.

Encadrer et accompagner les membres de lquipe.

Participer des prsentations pour le dveloppement commercial.

Contribuer la formation et lamlioration des processus du dpartement.

Accepter dautres responsabilits selon les comptences et la formation reue.

Profil recherch: Profil idal Education: Baccalaurat en sciences dans un domaine li la recherche clinique.

Expriences Minimum de 7 ans dexprience dans lindustrie, dont au moins 5 ans en gestion de projets dessais cliniques de phase I III, avec responsabilit financire.

Aptitudes et connaissances Exprience dans la gestion simultane dessais cliniques multicentriques et multinationaux, avec des budgets suprieurs 25 millions USD.

Certification PMP souhaite.

Une exprience dans un ou plusieurs des domaines suivants est considre comme un atout : gestion des cots dmarrage dtude soumissions rglementaires gestion des ressources supervision rle dARC gestion des donnes rdaction mdicale gestion des fournisseurs Exprience thrapeutique en dermatologie considre comme un atout.

Excellente connaissance des BPC (GCP), des normes ICH, des rglementations FDA et locales.

Trs bonne matrise de la suite Microsoft Office.

Matrise de langlais, avec dexcellentes comptences orales et crites requises.

Bilinguisme (anglais + langue locale) est un atout.

Capacit travailler en quipe et tablir de bonnes relations avec les collgues et les sponsors.

Bonnes comptences en rsolution de problmes.

Capacit grer plusieurs projets simultanment et travailler sous pression tout en respectant les dlais.

Bonne connaissance des bonnes pratiques cliniques et des rglementations applicables de Sant Canada et de la FDA.

Notre entreprise: Environnement de travail Chez Indero, vous travaillerez aux cts de collgues brillants et motivs.

Nos valeurs fondamentales sont la collaboration, linnovation, la fiabilit et la ractivit.

Nous offrons un environnement de travail stimulant ainsi que de belles opportunits dvolution professionnelle.

Lieu de travail Ce poste est en tltravail, bas au Canada.

Des dplacements rguliers, incluant des voyages avec nuites et/ou des dplacements internationaux, sont requis dans le cadre de ce rle. propos dIndero Indero est une CRO spcialise en dermatologie.

Depuis sa cration en 2000, lorganisation sest btie une solide rputation grce la qualit de ses recherches et ses services dpassant les attentes de ses clients.

Base Montral, Indero poursuit sa croissance en Amrique du Nord et en Europe.

Engagement envers lquit Indero sengage offrir un traitement quitable et des opportunits gales tous les individus.

Des mesures dadaptation seront offertes tout au long du processus de recrutement et de slection aux candidats en situation de handicap, sur demande.

Seuls les candidats lgalement autoriss travailler au Canada seront considrs. IDEAL PROFILE Education B.

Sc. in a related field of study to clinical research; Experience At least 7 years industry experience and a minimum of 5 years in Phase I-III clinical trial project management with financial accountability.

Experience leading concurrent multi-centered, multinational clinical trials with budgets in excess of $25M USD. PMP certification desirable Experience in one or more of the following considered an asset: cost management, study start up, regulatory submission, resource management, supervisory experience, CRA, data management, medical writing, or vendor management; Therapeutic experience managing dermatology trials an asset Knowledge & skills Excellent knowledge of GCP and ICH standards, FDA and local country regulations; Excellent knowledge of Microsoft Office suite; Fluency in English with excellent oral and written skills, required Bilingualism (English and local language) is an asset Ability to work in a team environment and establish good relationships with colleagues and sponsors; Good problem-solving abilities; Strong ability to carry out different projects and work under pressure while meeting timelines Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines

📌 Senior Project Manager / Chef de projet principal, Early Phase and Translational Research, Canada (Montreal)
🏢 Indero
📍 Montreal