Job Type: Regular, Full-Time
Location: 600 West 10th Avenue, Vancouver, BC V5Z 4E6
Hours of Work: Monday to Friday; 0800-1600, 0830-1630, 0900-1700
Requisition number: #132241
As per the current Public Health Order, full vaccination against COVID-19 is a condition of employment with PHSA as of October 26, 2021.
The Clinical Project Manager (CPM) is part of the Provincial Clinical Trials Office and reports to the Manager, Provincial Clinical Trials. Working closely with the Principal Investigator (PI), the CPM is responsible for the operational management of clinical trials including investigator-initiated clinical trials (IITs), ensuring the compliance with regulatory guidelines, timelines, milestones and budget. Working with the cross-function teams of regulatory affairs, project manager, database manager, quality assurance, budget and finance, and vendors, the CPM is responsible for the planning, execution, implementation, and management of all components of active Phase I – III IITs including analyzing risk assessment, developing process and tools for the successful completion of trial activities.
What you’ll do
- Consult with the PI and other stakeholders on an ongoing basis to determine opportunities for new investigator-initiated trials.
- Lead and file CTA applications with Health Canada and/or FDA and be point of contact for all communication with the regulatory agencies.
- Work with the study team and be responsible for the operational aspects of clinical trials at all sites and ensure compliance with standard operating procedures (SOP), good clinical practice (GCP) and applicable regulations.
- Oversee development of clinical documents, including clinical plans, protocols, forms, and reports.
- Work with Clinical Trial Monitors to ensure progress of clinical trials and follow up with team members and PI to resolve or mitigate any issues or challenges.
What you bring
- A level of education, training, and experience equivalent to a Bachelor’s degree in Health Sciences or related field, plus a minimum of three (3) to five (5) years of experience in managing clinical studies including experience using data analysis programs and electronic data capture (EDC) and Clinical Trials Management Systems (e.g., REDCapRealTime).
- Thorough understanding of regulatory guidelines including GCP, ICH E.6 R2 guidelines and industry standards.
You will also be able to demonstrate:
- Ability to manage multiple projects and prioritize them as needed.
- Demonstrated ability to work in cross-functional team environment and manage conflict in a complex team setting.
- Experience in using project management tools and concepts including ability to plan and organize, manage timelines, and troubleshoot.
- Sound understanding of clinical trials with a specialization in oncology.
- Excellent interpersonal, management, coordination and communication skills
What we bring
Every PHSA employee enables the best possible patient care for our patients and their families. Whether you are providing direct care, conducting research, or making it possible for others to do their work, you impact the lives of British Columbians today and in the future. That’s why we’re focused on your care too – offering health, wellness, development programs to support you – at work and at home.
- Join one of BC’s largest employers with province-wide programs, services and operations – offering vast opportunities for growth and development.
- Access to professional development opportunities through our in-house training programs, including +2,000 courses, such as our San’yas Indigenous Cultural Safety Training course, or Core Linx for Leadership roles.
- Enjoy a comprehensive benefits package, including municipal pension plan, and psychological health & safety programs and holistic wellness resources.
- Annual statutory holidays (13) with generous vacation entitlement and accruement.
- PHSA is a remote work friendly employer, welcoming flexible work options to support our people (eligibility may vary, depending on position).
- Perks include access to fitness classes and discounts to 350 BC-wide recreational programs, travel, technology, car and bike sharing, and more.