Senior Project Manager / Chef de projet principal, Early Phase and Translational Research, Canada

Description

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 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

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

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.

Description de poste

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

Le/la Chef de projet principal EPTR supervise et gère des projets cliniques nationaux, régionaux et/ou internationaux. Il/elle est responsable de la constitution et de la gestion des équipes projet, des communications, des risques, du périmètre, du calendrier, des coûts, de la qualité et des parties prenantes. Il/elle veille à ce que les écarts par rapport au plan soient anticipés et gérés efficacement, tout en répondant aux attentes du client.

Le/la Sr. PM EPTR doit avoir une bonne connaissance du développement de médicaments et de la conduite des essais cliniques. Il/elle est responsable de l'initiation, de la planification, de l'exécution, du suivi, du contrôle et de la clôture des essais cliniques qui lui sont confiés. Il/elle est le principal point de contact pour les parties prenantes et contribue à la faisabilité, à la conception de l'étude, à l'élaboration du budget et au suivi de l'avancement (ressources, budget, délais).

Il/elle agit également comme mentor, forme les autres chefs de projet et contribue activement aux efforts d'amélioration continue du département.

Responsabilités principales

• Agir comme point de contact principal pour le promoteur, les sites, les ARC, les fournisseurs et l'équipe interne.
• Veiller à ce que les études soient toujours prêtes pour un audit (formations, fichiers centraux, validation des systèmes, etc.).
• Communiquer efficacement avec les sponsors, les membres de l'équipe, les départements fonctionnels et la direction.
• Gérer les conflits et les problèmes du projet de manière proactive.
• Superviser les aspects opérationnels : délais, budget, ressources, fournisseurs.
• Contrôler le budget du projet et identifier les activités hors périmètre.
• Fournir des mises à jour régulières sur l'avancement de l'étude.
• Définir les indicateurs de performance clés (KPI) et s'assurer qu'ils respectent le contrat.
• Gérer les besoins en ressources et établir des plans de succession.
• Diriger le démarrage de l'étude : réunion de lancement, TMF, sélection et activation des sites, fournisseurs, contrats.
• Gérer les risques et assurer la qualité du projet.
• Diriger les réunions avec les clients, les fournisseurs et les équipes internes.
• Surveiller la qualité des livrables et proposer des améliorations.
• Analyser les écarts et mettre en œuvre des actions correctives.
• Maintenir à jour la matrice de formation spécifique au projet.
• Vérifier que tous les membres de l'équipe sont correctement formés.
• Examiner et approuver les réponses aux audits qualité.
• Veiller à ce que les documents de l'étude soient livrés dans les délais et conformes.
• Superviser le classement et l'archivage des documents dans le TMF.
• Fournir des mises à jour de statut conformes aux SOP, BPC et exigences réglementaires.
• Gérer le recrutement et proposer des actions pour éviter les retards.
• Participer à l'organisation des réunions investigateurs.
• Collaborer avec les affaires réglementaires pour les soumissions et la gestion des documents essentiels.
• Superviser les activités de monitoring : qualification, initiation, visites de routine et de clôture.
• Contribuer au plan de monitoring clinique.
• Former les ARC et éventuellement réaliser des visites d'initiation.
• Développer les outils de monitoring (rapports, grilles de vérification).
• Servir de point de contact pour les ARC.
• S'assurer que les sites disposent du matériel nécessaire.
• Collaborer avec la gestion des données pour garantir la conformité du CRF et le respect des délais jusqu'au verrouillage de la base.
• Encadrer et accompagner les membres de l'équipe.
• Participer à des présentations pour le développement commercial.
• Contribuer à la formation et à l'amélioration des processus du département.

Accepter d'autres responsabilités selon les compétences et la formation reçue.

Profil recherché

Profil idéal

Education:

• Baccalauréat en sciences dans un domaine lié à la recherche clinique.

Expériences

• Minimum de 7 ans d'expérience dans l'industrie, dont au moins 5 ans en gestion de projets d'essais cliniques de phase I à III, avec responsabilité financière.

Aptitudes et connaissances

• Expérience dans la