Job Description

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 Investigator's 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.



Requirements:

IDEAL PROFILE

B.Sc. in a related field of study to clinical research; 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 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


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 opportunity 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 - Fr:

Chef de projet principal - Phase precoce et recherche translationnelle (Sr. PM, EPTR)

Le/la Chef de projet principal EPTR supervise et gere des projets cliniques nationaux, regionaux et/ou internationaux. Il/elle est responsable de la constitution et de la gestion des equipes projet, des communications, des risques, du perimetre, du calendrier, des couts, de la qualite et des parties prenantes. Il/elle veille a ce que les ecarts par rapport au plan soient anticipes et geres efficacement, tout en repondant aux attentes du client.


Le/la Sr. PM EPTR doit avoir une bonne connaissance du developpement de medicaments et de la conduite des essais cliniques. Il/elle est responsable de l'initiation, de la planification, de l'execution, du suivi, du controle et de la cloture des essais cliniques qui lui sont confies. Il/elle est le principal point de contact pour les parties prenantes et contribue a la faisabilite, a la conception de l'etude, a l'elaboration du budget et au suivi de l'avancement (ressources, budget, delais).


Il/elle agit egalement comme mentor, forme les autres chefs de projet et contribue activement aux efforts d'amelioration continue du departement.

Responsabilites principales

Agir comme point de contact principal pour le promoteur, les sites, les ARC, les fournisseurs et l'equipe interne. Veiller a ce que les etudes soient toujours pretes pour un audit (formations, fichiers centraux, validation des systemes, etc.). Communiquer efficacement avec les sponsors, les membres de l'equipe, les departements fonctionnels et la direction. Gerer les conflits et les problemes du projet de maniere proactive. Superviser les aspects operationnels : delais, budget, ressources, fournisseurs. Controler le budget du projet et identifier les activites hors perimetre. Fournir des mises a jour regulieres sur l'avancement de l'etude. Definir les indicateurs de performance cles (KPI) et s'assurer qu'ils respectent le contrat. Gerer les besoins en ressources et etablir des plans de succession. Diriger le demarrage de l'etude : reunion de lancement, TMF, selection et activation des sites, fournisseurs, contrats. Gerer les risques et assurer la qualite du projet. Diriger les reunions avec les clients, les fournisseurs et les equipes internes. Surveiller la qualite des livrables et proposer des ameliorations. Analyser les ecarts et mettre en oeuvre des actions correctives. Maintenir a jour la matrice de formation specifique au projet. Verifier que tous les membres de l'equipe sont correctement formes. Examiner et approuver les reponses aux audits qualite. Veiller a ce que les documents de l'etude soient livres dans les delais et conformes. Superviser le classement et l'archivage des documents dans le TMF. Fournir des mises a jour de statut conformes aux SOP, BPC et exigences reglementaires. Gerer le recrutement et proposer des actions pour eviter les retards. Participer a l'organisation des reunions investigateurs. Collaborer avec les affaires reglementaires pour les soumissions et la gestion des documents essentiels. Superviser les activites de monitoring : qualification, initiation, visites de routine et de cloture. Contribuer au plan de monitoring clinique. Former les ARC et eventuellement realiser des visites d'initiation. Developper les outils de monitoring (rapports, grilles de verification). Servir de point de contact pour les ARC. S'assurer que les sites disposent du materiel necessaire. Collaborer avec la gestion des donnees pour garantir la conformite du CRF et le respect des delais jusqu'au verrouillage de la base. Encadrer et accompagner les membres de l'equipe. Participer a des presentations pour le developpement commercial. Contribuer a la formation et a l'amelioration des processus du departement.

Accepter d'autres responsabilites selon les competences et la formation recue.




Profil recherche:

Profil ideal

Baccalaureat en sciences dans un domaine lie a la recherche clinique. Minimum de 7 ans d'experience dans l'industrie, dont au moins 5 ans en gestion de projets d'essais cliniques de phase I a III, avec responsabilite financiere. Experience dans la gestion simultanee d'essais cliniques multicentriques et multinationaux, avec des budgets superieurs a 25 millions USD. Certification PMP souhaitee. Une experience dans un ou plusieurs des domaines suivants est consideree comme un atout : gestion des couts demarrage d'etude soumissions reglementaires gestion des ressources supervision role d'ARC gestion des donnees redaction medicale gestion des fournisseurs Experience therapeutique en dermatologie consideree comme un atout. Excellente connaissance des BPC (GCP), des normes ICH, des reglementations FDA et locales. Tres bonne maitrise de la suite Microsoft Office. Maitrise de l'anglais, avec d'excellentes competences orales et ecrites requises. Bilinguisme (anglais + langue locale) est un atout. Capacite a travailler en equipe et a etablir de bonnes relations avec les collegues et les sponsors. Bonnes competences en resolution de problemes. Capacite a gerer plusieurs projets simultanement et a travailler sous pression tout en respectant les delais. Bonne connaissance des bonnes pratiques cliniques et des reglementations applicables de Sante Canada et de la FDA.



Notre entreprise:

Environnement de travail

Chez Indero, vous travaillerez aux cotes de collegues brillants et motives. Nos valeurs fondamentales sont la collaboration, l'innovation, la fiabilite et la reactivite. Nous offrons un environnement de travail stimulant ainsi que de belles opportunites d'evolution professionnelle.

Lieu de travail

Ce poste est en teletravail, base au Canada.


Des deplacements reguliers, incluant des voyages avec nuitees et/ou des deplacements internationaux, sont requis dans le cadre de ce role.

A propos d'Indero

Indero est une CRO specialisee en dermatologie. Depuis sa creation en 2000, l'organisation s'est batie une solide reputation grace a la qualite de ses recherches et a ses services depassant les attentes de ses clients. Basee a Montreal, Indero poursuit sa croissance en Amerique du Nord et en Europe.

Engagement envers l'equite

Indero s'engage a offrir un traitement equitable et des opportunites egales a tous les individus. Des mesures d'adaptation seront offertes tout au long du processus de recrutement et de selection aux candidats en situation de handicap, sur demande.


Seuls les candidats legalement autorises a travailler au Canada seront consideres.




Brand name:


Indero