Clinical Trial Lead

2 weeks ago

Montreal, Quebec, Canada PSI CRO Full time
Company Description

PSI is a leading Contract Research Organization (CRO) with more than 25 years of experience in the pharmaceutical industry.

PSI is a privately-owned, full-service globally operating CRO.

PSI's global reach supports clinical trials across multiple countries and continents and we are known to be highly selective about the work we pursue.

We focus on delivering quality and on-time services across a variety of therapeutic indications.


With an exceptionally high repeat and referral business rate combined with mínimal staff turnover, PSI is committed to being the best CRO in the world as measured by its customers, employees, sites, and vendors.


Job Description:

The Clinical Trial Lead role is a remote-based position.


As a Clinical Trial Lead, you will have the opportunity to take on a leadership role and supervise all clinical aspects of full-service, global projects.

You will participate in the planning, implementation and management of projects in compliance with industry regulations, ICH-GCP and applicable controlled documents.

You will assume responsibility for the coordination of the project team in designated countries and the monitoring of daily activities.


Responsibilities include:

  • Manage clinical project timelines, milestones, schedules and updates during all project stages
  • Manage and report on Key Performance Indicator (KPI's); contribute to and participate in Project Review Meetings
  • Ensure consistency of all study processes across regions (if delegated)
  • Act as primary contact for the project team, i.e. CRAs, Project Assistants and PSI support services
  • Be a point of contact for contractors and third party vendors
  • Manage project teams in the region, including team building, quality compliance, training and monitoring of daily activities
  • Contribute to the development and update of project planning documents, essential documents, and project instructions
  • Oversee maintenance of studyspecific and corporate tracking systems

Qualifications:

  • Relevant educational background, such as MD, MPharm, RN or university/college degree in Life Sciences or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities.
  • Minimum 4 years' site monitoring experience and at least 2 years' experience as Lead Monitor/Clinical Trial Lead and verified experience of supervised work in the capacity of Regional Lead role or equivalent.
  • Full working proficiency in English
  • Excellent communication, presentation and customerservice skills
  • Strong ability to negotiate and build relationships at all levels
  • Exceptional team building, leadership and organizational skills
  • Ability to travel up to 25% (depending on project needs)
  • Valid driver's license (if applicable)
Additional Information


Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first You will get hands-on involvement in every aspect of the study.

  • Clinical Trial Administrator

    2 weeks ago

    Montreal, Quebec, Canada Fortrea Full time

    Clinical Trial AdministratorMontreal, QCHybrid 50% client office / 50% home-basedBilingual in English and French requiredAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of...

  • Clinical Trial Administrator

    2 weeks ago

    Montreal, Quebec, Canada Labcorp Full time

    Clinical Trial AdministratorMontreal, QCHybrid 50% client office / 50% home-basedWhy settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn't want twice the perks - working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic...

  • Clinical Trials Administrator I

    2 weeks ago

    Montreal, Quebec, Canada Labcorp Full time

    Clinical Trial Administrator - FSPHybrid Office/Home-Based - Montreal, QuebecMust be bilingual (English/French)As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the...

  • Clinical Trial Coordinator

    2 weeks ago

    Montreal, Quebec, Canada ICON plc Full time

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.What you will be doing:Clinical Trial Coordinator (CTC)Trial and site administration: Track (e.g....

  • Clinical Trial Monitor

    2 weeks ago

    Montreal, Quebec, Canada Centre universitaire de santé McGill Full time

    Organization descriptionLe Centre universitaire de santé McGill (CUSM) est un centre hospitalier universitaire intégré, reconnu à l'échelle internationale pour l'excellence de ses programmes cliniques, de sa recherche et de son enseignement. Le CUSM a pour objectif d'assurer aux patients des soins fondés sur les connaissances les plus avancées dans le...

  • Clinical Trial Coordinator

    2 weeks ago

    Montreal, Quebec, Canada ICON Full time

    As a Clinical Trial Coordinator you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.What you will be doing**:Clinical Trial Coordinator (CTC)Trial and site administration: Track (e.g. essential documents) and report (e.g. Safety Reports) Ensure collation and distribution of study...

  • Clinical Trial Coordinator

    2 weeks ago

    Montreal, Quebec, Canada Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Trial Coordinator

    2 weeks ago

    Montreal, Quebec, Canada Fortrea Full time

    Clinical Trial Coordinator - Regulatory Hybrid Montreal QCFortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we...

  • Clinical Trial Assistant

    2 weeks ago

    Montreal, Quebec, Canada NeuroRx Research Full time

    The role:The Clinical Trial Assistant provides administrative support to all Project Managers in their daily duties, including liaising with clinical sites and MRI facilities.These duties include but are no limited to the following: Submit requests for shipment of MRI supplies and trialspecific sFTP account creation Issuing trialspecific reports Issuing...

  • Clinical Trials Recruitment Coordinator

    2 weeks ago

    Montreal, Quebec, Canada dicentra Full time

    Welcome to dicentraLet's build a better world, togetherWhy join usBest workplace: We nourish an environment devoted to honesty and fairness, trust and respect. We care deeply for our team members and take worklife balance seriously, allowing our people to decide on a schedule that best fits their life and working preferences._Best people: We unite...

  • Fsp - Clinical Project Manager

    2 weeks ago

    Montreal, Quebec, Canada Allphase Clinical Research Inc. Full time

    Your responsibilities include, but are not limited to: - Lead local evidence generation strategy and operations for key products/indications; Endtoend management of local study design, analysis and communication of results for local clientsponsored studies; Management of local research budget forecast, management and reconciliation; Management of operations...

  • Clinical Trial Coordinator-regulatory

    2 weeks ago

    Montreal, Quebec, Canada Labcorp Full time

    Clinical Trial Coordinator - RegulatoryHybrid-CanadaAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more...

  • Clinical Trial Coordinator

    2 weeks ago

    Montreal, Quebec, Canada Labcorp Full time

    Clinical Trial Coordinator - Regulatory**Hybrid - Montreal QCWhy settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn't want twice the perks - working at one of the largest FSP CROs—and partnering with one sponsor with a dedicated therapeutic focus.Our Energizing...

  • Clinical Trial Coordinator-finance

    2 weeks ago

    Montreal, Quebec, Canada Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Clinical Research Manager

    2 weeks ago

    Montreal, Quebec, Canada Parexel Full time

    PXL is seeking a Clinical Research Manager (CRM) in Canada for one of our large FSP clients This is a remote position with some travel.Oncology experience is preferred Position Purpose:The Clinical Research Manager (CRM) is responsible for the following:Primarily accountable for end-to-end performance and project management for assigned protocols in a...

  • Senior Clinical Scientist, FSP Oncology

    2 weeks ago

    Montreal, Quebec, Canada CDS Fortrea Inc. Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • National Coordinator of Clinical Trials Training

    2 weeks ago

    Montreal, Quebec, Canada Centre universitaire de santé McGill Full time

    Organization descriptionLe Centre universitaire de santé McGill (CUSM) est un centre hospitalier universitaire intégré, reconnu à l'échelle internationale pour l'excellence de ses programmes cliniques, de sa recherche et de son enseignement. Le CUSM a pour objectif d'assurer aux patients des soins fondés sur les connaissances les plus avancées dans le...

  • Early Phase Project Manager Ii

    2 weeks ago

    Montreal, Quebec, Canada Syneos Health Clinical Full time

    DescriptionProject Manager IISyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve...

  • Sso Clinical Project Manager

    2 weeks ago

    Montreal, Quebec, Canada Novartis Full time

    100,000. That's how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients' lives every day acting as a link between science and medicine. Envision the impact you could have #GCOThe SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first...

  • Team Lead

    2 weeks ago

    Montreal, Quebec, Canada STATKING Clinical Services Career Site Full time

    Job Summary: In collaboration with the Senior Director of Data Management and Bioinformatics, develops and maintains software and database systems ensuring compliance with specifications security, quality controls and trains company personnel on the use of the software.Essential Functions: The following duties represent the principal job duties however they...