De la recherche aux applications concrètes, IQVIA intègre les technologies, les ressources et l’expertise nécessaires pour saisir de nouvelles occasions. En s’appuyant sur la science des données humaines, une fusion de la science des données, de la technologie et des sciences humaines, IQVIA aide ses clients à répondre aux besoins actuels et à saisir les occasions futures. Pour y parvenir, une intégration fluide de données inégalées, d’analyses avancées, de technologies transformatrices et d’une expertise approfondie est essentielle.
En tant que chef de file mondial, IQVIA met à profit les données, la technologie, les analyses avancées et son expertise pour faire progresser les soins de santé et la santé humaine. En collaboration avec les entreprises qu’elle dessert, IQVIA contribue à moderniser le système de santé pour le rendre plus efficace et efficient, en proposant des solutions novatrices qui transforment les entreprises, les soins de santé et les résultats pour les patients.
Au Canada, l’équipe de Real World Solutions accompagne ses clients en matière de stratégie d’accès au marché, d’économie de la santé et de recherche sur les résultats, en fournissant des analyses basées sur diverses bases de données du secteur de la santé ainsi que des preuves concrètes grâce à des études locales novatrices de phase IV. Ce service canadien est assuré par une équipe agile d’experts hautement qualifiés dans divers domaines thérapeutiques, soutenue par des solutions mondiales robustes pour collaborer avec les médecins et les patients, tout en maintenant une infrastructure simple et flexible, adaptée au marché canadien.

EDUCATION/QUALIFICATIONS:

• MSc, PhD, MD, PharmD (or equivalent industry experience)
• Min 5 years’ demonstrated experience delivering healthcare studies in an academic or research setting with thorough knowledge of the research/evidence generation landscape in Canada (e.g., data management process, data cleaning, SAE reconciliation, external vendor data reconciliation, management of central/local laboratory data, and/or new technology)
• Experience in Epidemiology, specialty, or a related area of study is advantageous
• Knowledge and understanding of the process of undertaking real-world or observational studies
• Knowledge of consulting methods, tools and techniques, related to one’s functional area
• Knowledge and understanding of the fundamental processes of business, their interaction, and the impact of external/internal influences on decision-making, growth and decline
• Skilled at using MS Office products including Word, PowerPoint and Excel is required; familiarity with other project management tools is an asset

EXPERIENCE:

You will typically have experience working in one of the following environments:

• An experienced and qualified Clinical Project Manager in academia, hospital, other life-science function, or a CRO
• A Project Manager in the Pharmaceutical Industry
• Previous experience in a study or clinical trial support role

TECHNICAL SKILLS AND KNOWLEDGE (ASSETS):

• Understanding of and interest in the Canadian and international health care environment, and evolving industry standards/challenges
• Good understanding of outcomes research theory, and practical knowledge of research project implementation
• Knowledge and understanding of ethics, regulatory, and/or site management activities is an asset
• High level of literacy – able to write reports in clear, accurate and concise language; experience with medical writing is an asset
• Numerate with good quantitative skills
• Conducting analyses in databases and/or registries
• Longitudinal patient-level data analysis
• Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines trained
• Certified Project Manager (or demonstrated experience)
• French is an asset

PERSONAL SKILLS AND BEHAVIORS:

• A friendly attitude
• A desire to do high quality work
• Exceptional detail-orientation
• Strong communication skills
• Ability to adapt quickly to situations and various social styles; to lead/thrive in ambiguity
• A team player with a desire to take a lead and make things happen
• A desire to manage several stakeholders with competing priorities
• Demonstrable analytical, interpretative, and problem-solving skills
• A good sense of urgency with the ability to prioritize tasks and manage time
• Ability to organize a list of tasks into logical steps and maintain progress
• Desire to constantly learn and take on new challenges
• Future leadership potential and desire to build a career with a top global corporation

FUNCTIONAL RESPONSIBILITIES

Lead the delivery of Real World Late Phase studies for clients in the pharmaceutical industry, governments, and academic centers in Canada, focusing on both retrospective and prospective real-world evidence generation studies.
Unlike a traditional Clinical Project Manager, the Consultant Project Manager leads an agile local team through the entire study continuum — from concept design, to start-up, investigator meetings, and client calls, data collection, close-out, reporting, and to dissemination of study results to the wider public audience.

ESSENTIAL FUNCTIONS OF A CONSULTANT/PROJECT MANAGER AT IQVIA CANADA FOR REAL-WORLD LATE PHASE STUDIES:

• Project Management: Oversee Late Phase research projects for the local Canadian market.
• Team Leadership: Lead an agile local team and coordinate with local/global internal and external cross-functional support teams to deliver high-quality real-world studies.
• Study Execution: Ensure effective and efficient planning, organization, communication, and execution of studies and study budgets.

KEY TASKS:

• Client Interaction:
• Review and analyze client requirements or problems.
• Develop proposals, budgets, and client solutions; assisting with data collection and data acquisition aspects of project proposals and protocols.
• Provide time estimates for design and implementation of proposed studies, and manage expectations.
• Run client meetings and/or meetings with key opinion leaders.
• Effectively communicate with stakeholders throughout the various phases of the study.
• Project Management & Implementation:
• Lead various aspects of the implementation of the project plan, managing scope, timeline, resourcing, and budget.
• Liaise between internal and external vendors.
• Negotiate external vendor contracts, establish vendor requirements and specifications, and provide oversight
• Develop detailed study documentation and specifications.
• Lead workshops with clients and clinical stakeholders for evidence generation needs (e.g., CRFs, PROs, etc.)
• Lead data acquisition (with study team and external data holders) for external data sources such as patient support programs and clinical research centers.
• Responsible for the execution and quality of project-specific documentation such as project plans, protocol, paper CRFs, edit check specifications, UAT feedback, and data dictionaries for internal and client approval.
• Consult with the study team to discern project-required data management reporting requirements and translate them into specifications for implementation by technical counterparts.
• Oversee project activities across multiple functional areas (e.g., project management, data management, site management, safety management, vendor management, biostatistics, finance management, etc.) by coordinating with local/global internal and external cross-functional support teams
• Quality Assurance:
• Oversee and ensure the quality of deliverables.
• Ensure accurate adherence to Standard Operating Procedures and quality processes.
• Manage study risk mitigation.
• Reporting:
• Prepare reports, including the design, structure, and completion of presentations tailored to the audience’s needs.
• Manage study dissemination through conferences and publications (e.g., manuscripts, abstracts, posters, presentations) with support from the study team.
• Oversee the maintenance of the Study Master File.
• Additional Responsibilities:
• Training of study analysts and new team members on study execution.
• May be assigned additional responsibilities as needed.
• Proactively develop a basic knowledge of consulting methodologies and the life sciences market through the delivery of consulting engagements and participation in formal and informal learning opportunities.