Clinical Project Manager

Keyrus Life Science North America; Montreal; Hybrid; CAD 80,000 - 100,000; Full time

Job summary

A fast-growing biotech company in Montreal is looking for an experienced Clinical Project Manager to oversee clinical trials. This role involves strategic planning, risk management, and team leadership. The ideal candidate must have a Master's degree in a scientific field and 5-8 years of experience in clinical operations, particularly in immuno-oncology. Benefits include competitive salary and RRSP contributions.

Benefits

Integrated benefits programs

RRSP contribution matching

Qualifications

• 5-8 years of experience in clinical operations including field follow-up.
• Experience in Phase I/II clinical trials in immuno-oncology.
• Knowledge of ICH GCP and applicable legislation.

Responsibilities

• Develop plans for initiating and executing clinical trials.
• Create and refine study protocols and related documents.
• Manage risks and ensure compliance with regulatory standards.

Skills

Clinical operations

Project management

Data analysis

Risk management

Team leadership

Education

Master’s degree in a scientific discipline

Tools

Clinical study management tools

Job description

Overview

The Clinical Project Manager (CPM) plays a crucial role in advancing the progress of clinical trials. Join this newly developing team in Canada with our client and grow your potential for the future. Let’s move to a brighter future and join a fast-growing, fast-paced biotech company.

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

Responsibilities

• Strategic Planning – Develop comprehensive plans for initiating, executing, and completing clinical trials, aligning them with project goals and timelines.
• Study Documents Development – Contribute to creating and refining study protocols, outlining methodology, objectives as well as the ICF, the eCRF and any other study related documents.
• Risk Management – Identify and manage risks associated with clinical trials and make recommendations. Ensure compliance with regulatory standards, timelines, and budgets.
• Team Leadership – Work hand to hand with Client European Clinical Head and extraordinary local support. Supervise clinical research associates and documentation specialists. Train team members on daily project operations.
• Vendor Management – Manage vendors to guarantee patient safety, contract adherence, and data integrity and financial engagement. Act as the primary contact for vendors.
• Documentation and Communication – Prepare and review documents related to clinical projects (contracts, vendor budgets, annual reports). Facilitate effective communication between research teams, sponsors, and regulatory authorities.
• Data Analysis and Reporting – Participate in data analysis, summary, and reporting for regulatory requirements.

Qualifications

• You have at least a Master’s degree in a scientific discipline (biology, biomedical sciences, pharmacy) or equivalent.
• You have 5-8 years of experience in clinical operations (including field follow-up) and CRO and supplier management is required.
• You have previous experience of Phase I/II clinical trials in the field of immuno-oncology.
• You have knowledge of ICH GCP and other legislation applicable to clinical studies.
• You are familiar with clinical study management tools and systems (eCRF databases).
• You are able to work independently and adapt to rapidly changing situations and needs.
• Strong commitment to high-quality work.
• You are keen to join a fast-growing, fast-paced biotech company.
• Other personal qualities: organized, pragmatic, flexible, persistent, open-minded, results-oriented.

Our offering

Salary as per experience plus benefits that meet their diverse and changing needs. We invest in integrated benefits programs and resources to take care of our employees. We will also match your RRSP contribution! Welcome to our great team!

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity. Our human approach to service provision differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.