Clinical Project Manager

Keyrus Life Science North America; Mount Royal; On-site; CAD 75,000 - 110,000; Full time

Job summary

Join a dynamic biotech company as a Clinical Project Manager, where you will lead clinical trials and ensure compliance with regulatory standards. This role offers the opportunity to collaborate with international teams and manage vendor relationships while driving project success. With a focus on quality and innovation, you will play a key role in advancing clinical research in a fast-paced environment. If you have a strong background in clinical operations and a passion for improving patient outcomes, this is the perfect opportunity to enhance your career in a supportive and growth-oriented setting.

Benefits

RRSP matching

Health benefits

Flexible working hours

Qualifications

• 5-8 years' experience in clinical operations and supplier management.
• Knowledge of ICH GCP and relevant legislation.

Responsibilities

• Manage and coordinate various aspects of clinical trials.
• Prepare and review documents related to clinical projects.

Skills

Clinical Operations

Risk Management

Vendor Management

Data Analysis

Team Leadership

Communication Skills

Knowledge of ICH GCP

Project Management

Education

Master's degree in a scientific discipline

Tools

eCRF databases

Job description

The Clinical Project Manager (CPM) plays a crucial role in advancing the progress of clinical trials. Join this emerging team in Canada with our client and enhance your career potential. Be part of a fast-growing, dynamic biotech company.

The Clinical Project Manager is an experienced professional in clinical research and healthcare management. Their responsibilities include managing and coordinating various aspects of clinical trials. Key duties and responsibilities include:

1. Strategic Planning:
   • Develop comprehensive plans for initiating, executing, and completing clinical trials, aligning with project goals and timelines.
2. Study Documents Development:
   • Contribute to creating and refining study protocols, outlining methodology, objectives, ICF, eCRF, and other study-related documents.
3. Risk Management:
   • Identify and manage risks associated with clinical trials and make recommendations.
   • Ensure compliance with regulatory standards, timelines, and budgets.
4. Team Leadership:
   • Collaborate with the European Clinical Head and local support. Supervise clinical research associates and documentation specialists.
   • Train team members on daily project operations.
5. Vendor Management:
   • Manage vendors to ensure patient safety, contract adherence, data integrity, and financial engagement.
   • Serve as the primary contact for vendors.
6. Documentation and Communication:
   • Prepare and review documents related to clinical projects (contracts, vendor budgets, reports).
   • Facilitate communication between research teams, sponsors, and regulatory authorities.
7. Data Analysis and Reporting:
   • Participate in data analysis, summarization, and reporting for regulatory purposes.
8. Your Skills:
   • Master's degree in a scientific discipline (biology, biomedical sciences, pharmacy) or equivalent.
   • 5-8 years' experience in clinical operations, including field follow-up, CRO, and supplier management.
   • Previous experience in Phase I/II immuno-oncology clinical trials.
   • Knowledge of ICH GCP and relevant legislation.
   • Familiarity with clinical study management tools (eCRF databases).
   • Ability to work independently and adapt quickly.
   • Strong commitment to quality.
   • Interest in joining a fast-paced, growing biotech environment.
   • Personal qualities: organized, pragmatic, flexible, persistent, open-minded, results-oriented.
9. Our Offering:
   • Salary based on experience plus benefits, including RRSP matching.
10. Who We Are:
    Keyrus Life Science is an international CRO and consulting organization committed to transparency, integrity, and excellence. We focus on delivering high-quality services across various stages of drug development, including project management, clinical operations, pharmacovigilance, and more.