[Hiring] Project Manager I @Indero

Role Description

The Project Manager I is involved in all phases of clinical trial project management. This person works closely with the Project Manager and functional team members. The Project Manager is responsible for tracking the study budget, project scope and timelines in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. The Project Manager will communicate project information to stakeholders, design templates, create presentations, review and edit project deliverables, and maintain the project information repository. The Project Manager will also help resolve project conflicts, identify resource requirements, and align the project team on project scope.

This role will be perfect for you if:

• We can count on you to deliver results while using a disciplined approach to project management.
• You are looking for the next career step to prepare you to become a project manager.
• You are knowledgeable about clinical research projects and looking to continue learning.
• Working in an organization that is driven by science and innovation and completing meaningful work is important to you.

Responsibilities

• Communicate project information to stakeholders including the Sponsor, vendors, and internal team members.
• Track and manage established plans to ensure all deliverables and milestones are met.
• Coordinate tasks and deadlines between the different departments involved in the project.
• Contribute to the management of needs and expectations of the Sponsor and other internal and external project stakeholders.
• Contribute to adequate training of team members on the project.
• Plan the activities and resources (e.g., internal and external resources, equipment, etc.) required for the project.
• Manage the quality of assigned work.
• Assist with providing project status updates.
• Analyze discrepancies between planned and actual results and participate in the development and implementation of corrective actions as needed.
• Assist with enforcing effective change control and risk management throughout the project.
• Develop/review project operational plans and manuals as applicable (e.g., project management plan, monitoring plan, etc.).
• Assist with ensuring that study-specific documents and project deliverables meet requirements.
• Participate in the planning and conduct of Investigator’s Meetings.
• Support the sites and ensure that each site has the necessary material to adequately perform the study.
• May oversee activities related to:
  • Site selection
  • Patient recruitment
  • Central ethics and regulatory submissions
  • Clinical monitoring activities
  • Data Management until database lock

Qualifications

• B.Sc. in a related field of study to clinical research.
• At least 3 years of experience in a similar role, including activities related to management of clinical studies in the pharmaceutical, biotechnology, and/or CRO industry.
• 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.
• Experience managing small to medium projects using a disciplined approach to project management.
• Demonstrated ability to establish and deliver resource-based project plans.
• Excellent people management skills; experience working with and managing teams in a matrix environment.

Benefits

• 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.

Company Description

Indero is a contract research organization (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.