Project Manager, Investigator Initiated Trials

Alberta Health Services; Edmonton; On-site; CAD 80,000 - 100,000; Full time

Job summary

Join a forward-thinking organization at the forefront of cancer treatment as a Project Manager in the Clinical Trials Unit. This role offers the opportunity to lead the setup and implementation of innovative investigator-initiated trials, ensuring compliance with regulatory standards and collaborating with a dedicated team of professionals. You'll play a crucial role in developing study protocols, managing multi-site activations, and enhancing processes within the program. If you have a passion for clinical research and a strong background in project management, this position is your chance to make a significant impact in the field of oncology.

Qualifications

• 5+ years of clinical trials experience with strong knowledge of Good Clinical Practice.
• Proven organizational skills and experience in project management.

Responsibilities

• Lead the setup and implementation of investigator-initiated cancer trials.
• Ensure compliance with ICH-GCP and manage relationships with internal and external departments.

Skills

Clinical Trials Experience

Project Management

Communication Skills

Problem-Solving

Organizational Skills

Education

Bachelor's Degree in a Related Field

Tools

MS Office

Connect Care

eCRF's

Redcap

Job description

Your Opportunity:

Be part of the leading edge of cancer treatment and join our Cross Cancer Institute Clinical Trials Unit. The Investigator-Initiated Trial (IIT) Project Manager will use their vast clinical trials experience to lead the setup and implementation of funded investigator-initiated cancer trials. They will work closely with physicians (Principal Investigators - PIs) to ensure development of properly constructed, ICH-GCP-compliant study protocols. The project manager will also ensure all necessary clinical trial approvals are obtained and required logistics are established, collaborating with our Regulatory team and Clinical Trials tumor group staff to plan and implement smooth study operations, while ensuring compliance with applicable laws and regulations. This position requires strong organization skills and regular collaboration with PIs, Clinical Trials Unit staff, Research Ethics, AHS or UofA Research staff, and other internal or external departments and sponsors.

Description:

Develop protocol procedures and coordinate the setup of investigator-initiated trials (IITs) in line with protocol requirements and project funding. Design and create case report forms and related study documents. Organize study processes for randomization, specimen handling, data capture, communication, tracking tools, and patient handouts. Assist investigators with applications to the CCI regional IIT committee. Complete ethics submissions and coordinate with AHS Research Administration for research and data transfer agreements. Manage relationships with internal and external departments, acting as the lead for multi-site study activations. Prepare reports for management and project tracking. Apply Good Clinical Practice and regulatory requirements to the conduct of IITs. Assist with Health Canada submissions and amendments. Participate in committees related to IITs and support Principal Investigators, nurses, and coordinators. Identify and implement process improvements within the IIT program.

• Location: Cross Cancer Institute
• Classification: Project Manager
• Union: Exempt
• Unit and Program: Clinical Trials Unit, Cancer Care
• Employee Class: Regular Full Time
• FTE: 1.00
• Posting End Date: 12-MAY-2025
• Date Available: 30-JUN-2025
• Hours per Shift: 7.75
• Shift Pattern: Days
• Days Off: Saturday/Sunday
• Salary Range: $30.00 - $51.54
• Vehicle Requirement: Not Applicable

Required Qualifications:

Bachelor's degree in a related field. Minimum 5 years of clinical trials experience, with excellent understanding of operations, setup, and coordination. Strong knowledge of Good Clinical Practice and Health Canada Division 5 regulations.

Additional Required Qualifications:

Strong leadership, communication, conflict resolution, writing, presentation, and facilitation skills. Proven organizational skills and experience in project management or multidisciplinary team coordination. Problem-solving and critical thinking abilities. Ability to prioritize tasks and manage multiple projects. Excellent computer skills (MS Office, Internet, Outlook) and experience with databases (e.g., Connect Care, eCRF's, Redcap). Strong team-building skills and capability to work independently and within a team. Physical demands include sitting for extended periods, lifting up to 40 lbs., and repetitive motions.

Preferred Qualifications:

Knowledge of oncology, completion of a Clinical Research or Project Management Program, SOCRA or ACRP certification, advanced data management skills, experience with clinical trial inspections, and monitoring procedures.