Job Description

The Clinical Project Manager (CPM) plays a crucial role in advancing the progress of clinical trials. Please join this newly developing team in Canada with our client, and quickly 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. Here are the key duties and responsibilities:

1. Strategic Planning :
• Develop comprehensive plans for initiating, executing, and completing clinical trials, aligning them with project goals and timelines.
2. 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.
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 :
• 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.
5. Vendor Management :
• Manage vendors to guarantee patient safety, contract adherence, and data integrity and financial engagement.
• Act as the primary contact for vendors.
6. 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.
7. Data Analysis and Reporting :
• Participate in data analysis, summary, and reporting for regulatory requirements.
8. Your Skills

- You have at least a Master's degree in a scientific discipline (biology, biomedical sciences, pharmacy) or equivalent.

- You have 5-8 years' 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.

9. 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 in 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, highly focused on being able to deliver with excellence. Our human approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to deliver services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.

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.

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