Project Manager - Dermatology/Rheumatology (Argentina)

Indero (anciennement Innovaderm); Montreal; Remote; CAD 85,000 - 120,000; Full time

Job summary

A contract research organization in Montreal is seeking a Project Manager to lead critical clinical trials. The ideal candidate will have over 5 years in the industry, including significant experience managing multi-center trials and a solid understanding of GCP standards. You will oversee project deliverables and be the main contact with clients while ensuring timely execution within budget. An attractive flexible work environment with growth opportunities awaits you.

Benefits

Flexible work schedule

Home-based position

Ongoing learning and development opportunities

Qualifications

• At least 5 years of industry experience.
• Minimum 3 years leading multi-center clinical trials (phase II-III).
• Experience with clinical trials exceeding $3M USD budgets.

Responsibilities

• Serve as primary contact for sponsors.
• Lead core project team including Associate Project Managers.
• Control project budget and manage timelines.

Skills

Leadership

Problem-solving

Team Collaboration

Time Management

GCP and ICH Standards Knowledge

Education

B.Sc. in relevant discipline

Tools

Microsoft Office Suite

Job description

Projects Managers are crucial to the success of Clinical Trials managed by Indero. They are the main point of contact internally as well as externally, ensuring all activities and deliverables are completed on time, on budget, and as expected.

Great project managers go further than creating project plans and following up on tasks. They show leadership to help project teams focus on objectives and deliver results.

This role will be perfect for you if:

• You want to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projects
• You are looking to position yourself in an environment where you can grow your career alongside the company
  
  

Impact And Responsibilities

Client interactions

• Serve as primary contact for the Sponsor
• Provide efficient and timely updates on trial progress
• Lead client calls effectively
  
  

Project planning

• Oversee and actively participates in the preparation of project deliverables such as; study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.
• Participate in the planning and conduct of the Investigator’s Meeting.
• Ensure that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).
  
  

Quality and risk management

• Ensure assigned studies are “audit ready” at all times.
• Monitor the quality of study deliverables, (including vendor and SubCRO deliverables) and address issues as they arise.
• Manage risk and control measures to assure project quality.
• Analyze discrepancies between planned and actual results.
• Review and approve responses to quality assurance audits.
  
  

Project budget and timelines

• Control the project budget, with particular attention to internal hours allocated to all activities.
• Identify out of scope activities for change orders.
• Proactively manage operational aspects of the clinical trial including trial timelines, budget, resources and vendors. Coordinate tasks and deliverables from all functional departments involved in the project.
• Communicate effectively with study team members, functional departments, and senior management.
• Manage and report on recruitment status and highlight initiatives needed to meet recruitment timelines.
  
  

Project team leadership

• Lead the core project team which may include: Associate Project Managers, Project Coordinators, Project Assistants.
• Ensure all team members have adequate training on the project.
• Work closely with vendors and the following internal teams to ensure all tasks and deliverables are completed on time, according to plans and according to applicable standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, Scientific Affairs.
  
  

Requirements:

IDEAL PROFILE

Education

• B.Sc. in a relevant discipline
  
  

Experience

• At least 5 years of industry experience, including a minimum of 3 years leading multi-center clinical trials (phase II-III)
• Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD
• Experience managing dermatology trials
• Experience managing rheumatology trials an asset
  
  

Knowledge And Skills

• Excellent knowledge of GCP and ICH standards, FDA and local country regulations
• Excellent knowledge of Microsoft Office suite
• Fluency in English with excellent oral and written skills, required
• Ability to work in a team environment and establish good relationships with colleagues and sponsors
• Good problem-solving abilities
• Strong ability to carry out different projects and work under pressure while meeting timelines
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
  
  

Our company:

The Work Environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Flexible work schedule
• Home-based position
• Ongoing learning and development opportunities
  
  

About Indero

Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has built a strong reputation for delivering high-quality research and services that exceed client expectations. Based in Montreal, Indero continues to grow and expand across North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Argentina.