Clinical Studies Phase II to IV Project Manager

1 week ago

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

Project Manager, Clinical Studies Phase II to IV

We are seeking a highly skilled Project Manager to join our team at the Montreal Health Innovations Coordinating Center. The successful candidate will be responsible for managing clinical studies from Phase II to IV, ensuring timely completion and high-quality results.

Key Responsibilities

  • Develop and implement project management plans to ensure study timelines and deliverables are met
  • Collaborate with study teams to review protocol, Case Report Form (CRF), Investigator Brochure, and other study-related documents
  • Generate study management plans, monitoring plans, recruitment plans, and communication plans in collaboration with MHICC management and sponsors
  • Organize study start-up activities, including investigator recruitment and selection, collection of regulatory documents, IRB/EC submissions, and participation in Investigator meeting planning and execution
  • Ensure compliance with ICH/GCP/local law on clinical trial documentation and record retention guidelines
  • Develop study-specific and project management tools to ensure consistency and quality data
  • Provide training to internal and external study personnel on protocol, CRF completion, adverse event reporting, laboratory sample handling/shipping, and study requirements
  • Prepare and present monthly progress reports to MHICC upper management
  • Ensure the distribution of study drugs, central laboratories supplies, and other essential study supplies as required
  • Manage correspondence and information between sponsors, sites, Clinical Research Associates (CRAs), subcontractors, suppliers, vendors, and MHICC
  • Review and approve clinical monitoring reports
  • Ensure the review of the clinical trial master file for completeness
  • Provide work instructions/guidelines to assigned Clinical Trial Assistants and CRAs
  • Proactively identify and resolve issues that could jeopardize the timely completion of the trial
  • Assist sites in preparation for sponsor, regulatory agencies, or MHICC audits
  • Participate in MHICC and/or sponsor required training programs
  • Ensure that sponsor requirements, timelines, and deliverables are met

Requirements

  • Master's or Bachelor's degree in life sciences or related discipline and 4 years of experience in clinical research and project management in the pharmaceutical industry, biotechnology, or contract research organization
  • Strong leadership, project management, and interpersonal skills
  • Excellent analytical and problem-solving skills
  • Prioritize effectively
  • Excellent organization, communication, and management skills, as well as leadership skills
  • Bilingualism (French/English) - Mandatory
  • Computer literacy and proficiency in Microsoft Office, including Excel

Working Conditions

  • 35 hours weekly base
  • Pre-approved overtime paid
  • Flexible work schedule for work-family balance
  • Hybrid model (working from home and office)
  • 4 weeks' vacation after one year
  • 13 statutory holidays
  • Defined retirement benefits
  • Group insurance
  • 9.6 sick days

We are proud to offer a wide range of benefits aimed at the health, well-being, and quality of work life of our employees, including free access to the EPIC Center, Recharjme cabins, and quiet rooms, as well as various other benefits.

Only those selected for the selection process will be contacted.

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