Project Manager II / Project Manager II (Canada)

Role Summary

Description

The project manager II has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The project manager II oversees and coordinates study resources to ensure 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. Project Manager II 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)

This role will be perfect for you if

You want to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projects

You are looking to position yourself in an environment where you can grow your career alongside the company

Ce rôle est fait pour vous si

Vous souhaitez évoluer dans une CRO de taille intermédiaire impliquée dans des essais multicentriques d’envergure, incluant des projets globaux de Phase III

Vous recherchez un environnement vous permettant de faire progresser votre carrière en parallèle avec la croissance de l’entreprise

IMPACT ET RESPONSABILITÉS

• Interactions avec le client
• Agir comme principal point de contact pour le Sponsor
• Fournir des mises à jour claires, efficaces et en temps opportun sur l’avancement de l’étude
• Animer efficacement les réunions avec le client
• Planification du projet

Superviser et participer activement à la préparation des livrables du projet tels que : plans d’étude, protocole, formulaire de consentement éclairé, electronic case report form (eCRF), tables/listings/figures (TLFs), rapport d’étude clinique

Participer à la planification et à la tenue des Investigator’s Meetings

S’assurer que chaque site dispose du matériel nécessaire pour mener l’étude (ex.

: experimental product, supplies, specialized equipment, laboratory kits, etc.)

Lead the study start-up activities, including the trial kick-off, the implementation of the TMF, the selection and activation of sites, the coordination of vendor implementation deadlines as well as the contracting and budgeting of the sites

Collaborate with the Regulatory Affairs team to ensure timely submissions and completeness of essential documents prior to site initiation and throughout the study

Collaborate with Data Management to ensure alignment of the CRF with the sponsor's protocol and requirements, as well as compliance with deadlines related to data review, query resolution and database lock

• Quality and risk management
• Ensure assigned studies are ready at all times for audits and inspections
• Monitor the quality of study deliverables (including those from vendors and SubCRO) and address issues as they arise
• Implement and manage risk control measures to ensure project quality
• Analyze gaps between planned and actual results
• Review and approve responses to quality audits
• Project budget and timelines
• Ensure control of the project budget, particularly with regard to the allocation of internal hours for each activity
• Identify activities outside the scope in order to generate change orders

Proactively manage the operational aspects of the clinical trial, including timelines, budget, resources and vendors, and coordinate the activities of the different functions involved

• Communicate effectively with project team members, functional departments and management
• Monitor recruitment and identify the actions necessary to meet deadlines
• Leadership of the project team
• Lead the central project team which may include: Associate Project Managers, Project Coordinators, Project Assistants
• Ensure that all team members receive adequate training on the project

Collaborate closely with the following vendors and internal teams to ensure delivery of activities on time, according to applicable plans and standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, Scientific Affairs

• Define and maintain the project-specific training matrix and ensure that training files are up to date throughout the study
• Profile sought
• Training
• Bachelor's degree (BSc) in a field related to clinical research

Responsibilities

IMPACT AND RESPONSIBILITIES

• Client interactions
• Serve as primary contact for the Sponsor
• Provide efficient and timely updates on trial progress
• Lead client calls effectively
• Project planning
• Oversee and actively participates in the preparation of project deliverables such as; study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.
• Participate in the planning and conduct of the Investigator’s Meeting.
• Ensure that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).
• Lead study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor set-up timelines, and site contracting and budgeting.
• Collaborate with Regulatory Affairs to ensure timely submissions and completeness of essential documents prior to site initiation and throughout the study.
• Partner with Data Management to ensure CRF alignment with protocol and sponsor requirements, and that data review, query resolution, and database lock timelines are met.

Quality and risk management

• Ensure assigned studies are “audit ready” at all times.
• Monitor the quality of study deliverables, (including vendor and SubCRO deliverables) and address issues as they arise.
• Manage risk and control measures to assure project quality.
• Analyze discrepancies between planned and actual results.
• Review and approve responses to quality assurance audits.

Project budget and timelines

• Control the project budget, with particular attention to internal hours allocated to all activities.
• Identify out of scope activities for change orders.
• Proactively manage operational aspects of the clinical trial including trial timelines, budget, resources and vendors. Coordinate tasks and deliverables from all functional departments involved in the project.
• Communicate effectively with study team members, functional departments, and senior management.
• Manage and report on recruitment status and highlight initiatives needed to meet recruitment timelines.

Project team leadership

• Lead the core project team which may include: Associate Project Managers, Project Coordinators, Project Assistants.
• Ensure all team members have adequate training on the project.
• Work closely with vendors and the following internal teams to ensure all tasks and deliverables are completed on time, according to plans and according to applicable standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, Scientific Affairs.
• Define and maintain the project-specific training matrix and ensure training records are kept up to date throughout the study.

Requirements

Education

• B.Sc. in a related field of study to clinical research
• At least 5 years industry experience and a minimum of 3 years in Phase I-III clinical trial project management

Experience managing dermatology and/or rheumatology trials

Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD.

• Experience managing dermatology trials an asset
• Knowledge and skills
• Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations
• Excellent knowledge of Microsoft Office suite
• Excellent oral and written skills in English, French is an asset
• Excellent communication skills
• Ability to work in a team environment and establish good relationships with colleagues and sponsors
• Good problem-solving abilities
• Good organizational skills
• Strong ability to carry out different projects and work under pressure while meeting timelines
• Minimum of 5 years of experience in the industry, including at least 3 years in management of phase I to III clinical trial projects
• Experience in managing dermatology and/or rheumatology trials
• Experience in simultaneously managing multicenter clinical trials with budgets greater than $3M USD
• Experience in dermatology is an asset
• Knowledge and skills
• Excellent knowledge of GCP and ICH standards, as well as FDA and Canadian regulations
• Excellent command of the Microsoft Office suite
• Excellent oral and written communication skills in English, French is an asset
• Excellent communication skills
• Ability to work in a team and establish good relationships with colleagues and sponsors
• Good problem-solving skills
• Good organizational skills
• Strong ability to manage multiple projects simultaneously and work under pressure while meeting deadlines

Location

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 opportunities for advancement.

• In this position, you will be eligible for the following perks:
• Flexible work schedule
• Permanent full-time position
• Comprehensive benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
• Ongoing learning and development opportunities

The successful candidate for this position has the option to work remotely anywhere in Canada, or from our headquarters in Montreal (in accordance with company policies and public health directives).

Occasional visits to our Montreal office may be required or encouraged.

About Indero

Indero is a CRO specialized in clinical trials. Based in Montreal, we have built a strong reputation for the quality of our research and services that exceed client expectations. Indero continues to grow and expand across North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. Accommodations are available throughout the recruitment and selection process for applicants with disabilities, upon request.

Please note that Indero only accepts applicants who are legally authorized to work in Canada.

Description de poste

Le/la gestionnaire de projet II est responsable de la réussite globale de l’initiation, de la planification, de l’exécution, du suivi, du contrôle et de la clôture des essais cliniques qui lui sont assignés. Le/la gestionnaire de projet II supervise et coordonne les ressources de l’étude afin d’assurer le respect du budget, du périmètre et des échéanciers, conformément aux procédures opératoires normalisées (SOPs), aux bonnes pratiques cliniques (GCP), ainsi qu’aux exigences réglementaires et spécifiques à l’étude. Il/elle agit comme principal point de contact auprès des parties prenantes et contribue à la faisabilité, à la conception de l’étude, à l’élaboration du budget, tout en assurant un suivi rigoureux de l’avancement (ressources, budget et échéanciers).

At Indero, you will work with competent and dynamic colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment as well as great prospects for professional development.

• In this position, you will benefit from the following conditions:
• Flexible work schedule
• Permanent full-time position

Full range of benefits (medical, dental, vision insurance, retirement plan, vacation, personal days, virtual medical clinic, discounts on public transportation, social activities)

Training and continuous development

Workplace

The hired person will be able to work remotely from any city in Canada, or from our main office in Montreal (in accordance with company policies and public health directives).

Occasional visits to our headquarters may be required or encouraged.

About Indero

Indero is a contract clinical research organization (CRO) specializing in clinical trials.

Since its beginnings, our human-sized company has built a solid reputation for the quality of its research and services, surpassing the expectations of our clients. Based in Montreal, Indero continues its growth across North America and Europe.

Indero is committed to providing fair treatment and equal opportunities to all applicants. Accommodations can be offered at any stage of the recruitment process for people with disabilities, upon request.

Indero only accepts applications from individuals legally authorized to work in Canada.

The masculine gender is used without discrimination, for the sole purpose of lightening the text.