Clinical Project Manager

1 week ago

Montreal, Quebec, Canada Syneos Health Full time
About the Role

We are seeking a highly skilled Clinical Trial Manager to join our team at Syneos Health. As a Clinical Trial Manager, you will be responsible for overseeing the clinical trial management process, ensuring the successful execution of clinical trials, and maintaining high-quality standards.

Key Responsibilities
  • Site Management Oversight: Responsible for site management oversight, clinical monitoring, and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance, and data integrity.
  • Study Coordination: Oversees site interactions post-activation through site closeout, including patient recruitment, investigator payments, and other related activities.
  • Risk Management: Identifies critical data and process, protocol execution risks, and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
  • Project Oversight: Reviews the study scope of work, budget, and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters.
  • Risk Mitigation: Uses prior clinical experience, operational data, metrics, and reports to identify risks to clinical trial management deliverables and escalates to the project manager any risks to clinical trial management deliverables (timeline, quality, and budget).
  • Strategic Thinking: Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
  • Communication: Participates and presents in key meetings, such as Kick Off Meetings, and serves as an escalation point for communications with investigator site staff.
  • Collaboration: Collaborates with other functional leaders, such as Study Start Up, Patient Recruitment, and Data Management, to coordinate delivery handoffs and meet expected study milestones.
  • Quality Assurance: Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan, and ensures CTMS, dashboards, and other systems are set up and available for use by the clinical team.
  • Training and Development: Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans, and guidelines.
  • Performance Management: Oversees resourcing allocations for CRAs and Central Monitors, site assignments, and study team members' conduct and identifies risks to delivery or quality.
  • Quality Control: Ensures quality of the clinical monitoring, central monitoring, and site management deliverables within a project and maintains proper visibility of its progress by the use of approved systems and/or tracking tools.
  • Monitoring Strategy: Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan.
  • Documentation: Reviews the content and quality of site and central monitoring documentation, including site monitoring calls, site visit reports, site letters, central monitoring reports, and pertinent correspondence.
  • Client Communication: Interacts with the client and other functional departments related to clinical monitoring, central monitoring, and site management activities and deliverables.
  • Problem-Solving: Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations.
  • Inspection Readiness: Supports Inspection Readiness for clinical trial management scope.
  • Staff Development: Provides feedback to line managers on staff performance, including strengths and areas for development.
Requirements
  • Education: Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
  • Leadership: Demonstrated ability to lead and align teams in the achievement of project milestones.
  • International Experience: Demonstrated capability of working in an international environment.
  • Site Management: Demonstrated expertise in site management and monitoring (clinical or central).
  • Risk-Based Monitoring: Preferred experience with risk-based monitoring.
  • Financial Management: Demonstrates understanding of clinical trial management financial principles and budget management.
  • Regulatory Knowledge: Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Computer Skills: Must demonstrate good computer skills.
  • Communication Skills: Good communication, presentation, and interpersonal skills among project team and with sites.
  • Conflict Resolution: Strong conflict resolution skills.
  • Problem-Solving: Demonstrated ability to apply problem-solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.

  • Lead Clinical Project Manager

    4 weeks ago

    Montreal, Quebec, Canada PSI CRO Full time

    Company OverviewPSI is a prominent Contract Research Organization with over 28 years of experience in the sector, providing an ideal blend of reliability and innovation for both clients and team members. Focus AreasWe are dedicated to delivering high-quality and timely services across a diverse range of therapeutic areas. Project Management Responsibilities~...

  • Clinical Operations Coordinator

    2 weeks ago

    Montreal, Quebec, Canada Syneos Health Full time

    Clinical Operations CoordinatorSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Department is seeking a highly skilled and organized Clinical Operations...

  • Senior Clinical Project Leader

    4 weeks ago

    Montreal, Quebec, Canada Institut de Cardiologie de Montréal Full time

    Senior Clinical Project Leader Position open only to Canadian citizen/resident or with Canadian work permit Full Time The Institut de Cardiologie de Montréal is a comprehensive contract research organization focused on multicenter and multinational clinical trials. We collaborate with the academic sector and the pharmaceutical, biotechnology, and medical...

  • Clinical Operations Manager

    4 weeks ago

    Montreal, Quebec, Canada Innovaderm Research Full time

    Position Overview:The Clinical Operations Manager plays a pivotal role in the oversight and management of clinical research activities. This position collaborates closely with the Director of the Clinical Research Unit and clinical personnel to ensure effective support throughout the various phases of clinical research management.Key Responsibilities:The...

  • Clinical Trial Management Specialist

    6 days ago

    Montreal, Quebec, Canada Syneos Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Trial Operations Manager to join our team at Syneos Health. As a key member of our clinical operations team, you will be responsible for overseeing the management of clinical trials, ensuring compliance with regulatory requirements, and driving project success.Key ResponsibilitiesSite Management Oversight:...

  • Clinical Trial Management Specialist

    1 week ago

    Montreal, Quebec, Canada Syneos Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Trial Operations Manager to join our team at Syneos Health. As a key member of our clinical operations team, you will be responsible for overseeing the management of clinical trials, ensuring compliance with regulatory requirements, and driving project success.Key ResponsibilitiesSite Management Oversight:...

  • Clinical Trial Management Specialist

    1 week ago

    Montreal, Quebec, Canada Syneos Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Trial Operations Manager to join our team at Syneos Health. As a key member of our clinical operations team, you will be responsible for overseeing the management of clinical trials, ensuring compliance with regulatory requirements, and driving project success.Key ResponsibilitiesManage site interactions,...

  • Clinical Trial Management Specialist

    5 days ago

    Montreal, Quebec, Canada Syneos Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Trial Operations Manager to join our team at Syneos Health. As a key member of our clinical operations team, you will be responsible for overseeing the management of clinical trials, ensuring compliance with regulatory requirements, and driving project success.Key ResponsibilitiesManage site interactions,...

  • Clinical Research Operations Manager

    2 days ago

    Montreal, Quebec, Canada Syneos Health Full time

    About the RoleWe are seeking a highly skilled Clinical Research Operations Manager to join our team at Syneos Health. As a key member of our clinical operations team, you will be responsible for overseeing site management and monitoring activities to ensure the successful execution of clinical trials.Key ResponsibilitiesSite Management Oversight: Responsible...

  • Clinical Research Operations Manager

    2 days ago

    Montreal, Quebec, Canada Syneos Health Full time

    About the RoleWe are seeking a highly skilled Clinical Research Operations Manager to join our team at Syneos Health. As a key member of our clinical operations team, you will be responsible for overseeing site management and monitoring activities to ensure the successful execution of clinical trials.Key ResponsibilitiesSite Management Oversight: Responsible...

  • Physiotherapy Clinic Manager

    5 days ago

    Montreal, Quebec, Canada Lifemark Health Group Full time

    Job Summary:Lifemark Health Group is seeking a highly skilled and experienced Clinic Director to lead the success of our clinics. As a key member of our team, you will be responsible for overseeing internal operations, clinical staff, and patient services, while driving business development and revenue growth.About the Role:Leadership and Management: Provide...

  • Physiotherapy Clinic Manager

    7 days ago

    Montreal, Quebec, Canada Lifemark Health Group Full time

    Job Summary:Lifemark Health Group is seeking a highly skilled and experienced Clinic Director to lead the success of our clinics. As a key member of our team, you will be responsible for overseeing internal operations, clinical staff, and patient services, while driving business development and revenue growth.About the Role:Leadership and Management: Provide...

  • Clinical Trial Management Specialist

    6 days ago

    Montreal, Quebec, Canada Syneos Health Full time

    Job SummarySyneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.As a Clinical Trial Operations Manager at Syneos Health, you will play a critical role in ensuring the successful execution of...

  • Clinical Trial Management Specialist

    1 week ago

    Montreal, Quebec, Canada Syneos Health Full time

    Job SummarySyneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.As a Clinical Trial Operations Manager at Syneos Health, you will play a critical role in ensuring the successful execution of...

  • Clinical Support Manager

    7 days ago

    Montreal, Quebec, Canada Innovaderm Full time

    Job SummaryThe Manager, Clinical Support will be responsible for leading the activities and overseeing the day-to-day management of the Clinical Research Unit, Regulatory Affairs, Clinical Research Coordinator Assistants and Team Lead, Laboratory staff, and Patient Recruitment teams.Key ResponsibilitiesManage performance, conduct formal performance reviews,...

  • Clinical Support Manager

    5 days ago

    Montreal, Quebec, Canada Innovaderm Full time

    Job SummaryThe Manager, Clinical Support will be responsible for leading the activities and overseeing the day-to-day management of the Clinical Research Unit, Regulatory Affairs, Clinical Research Coordinator Assistants and Team Lead, Laboratory staff, and Patient Recruitment teams.Key ResponsibilitiesManage performance, conduct formal performance reviews,...

  • Senior Clinical Trial Manager

    4 weeks ago

    Montreal, Quebec, Canada Syneos Health Full time

    Position Title: Clinical Trial Manager IIOrganization: Syneos HealthSyneos Health stands as a leading biopharmaceutical solutions provider committed to enhancing client success. Our expertise lies in converting unique clinical, medical affairs, and commercial insights into actionable results that address contemporary market challenges.Key Responsibilities:1....

  • Clinical Project Leader, Early Phase

    4 weeks ago

    Montreal, Quebec, Canada Innovaderm Research Full time

    Exciting Opportunity for Project Managers in the Clinical Trials SectorCompany OverviewInnovaderm Research is a premier contract research organization focused on dermatological studies. Renowned for its commitment to quality and research excellence, Innovaderm is actively broadening its reach across North America and Europe.Key ResponsibilitiesServe as the...

  • Clinical Support Manager

    4 weeks ago

    Montreal, Quebec, Canada Innovaderm Research Full time

    Clinical Support Manager, Head office, Montreal, Qc The Clinical Support Manager collaborates closely with the Director of the Clinical Research Unit and clinical personnel to oversee the team and provide assistance throughout the various phases of Clinical Research management. This role is accountable for directing the operations and supervising the...

  • Clinical Study Manager

    4 weeks ago

    Montreal, Quebec, Canada Bristol Myers Squibb Full time

    Position: Clinical Study ManagerLocation: Montreal (Saint-Laurent), QuebecEmployment Type: PermanentAt Bristol Myers Squibb, we redefine the concept of work. Here, you will engage in rewarding and impactful projects that truly make a difference in the lives of patients. Our diverse teams are committed to excellence, and you will have the opportunity to...