Clinical Research Project Manager - Toronto, Canada - SickKids

SickKids

Verified Company

Toronto, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

About SickKids:

Dedicated exclusively to children and their families, The Hospital for Sick Children (SickKids) is one of the largest and most respected paediatric healthcare centres in the world.

As innovators in child health, we lead and partner to improve the health of children through the integration of healthcare, leading-edge research and education.

Our reputation would not have been built - nor could it be maintained - without the skills, knowledge and experience of the extraordinary people who come to work here every day.

SickKids is committed to ongoing learning and development, and features a caring and supportive work environment that combines exceptionally high standards of practice.

When you join SickKids, you become part of our community. We share a commitment and determination to fulfill our vision of _Healthier Children. A Better World_.

Don't miss out on the opportunity to work alongside the world's best in paediatric healthcare.

Position Description:

We are currently looking for a
Clinical Research Project Manager to join the
Clinical Trials Support Unit (CTSU) team, part of the
Haematology/Oncology program.

This is an exciting opportunity for you to use your project management skills and clinical trial knowledge to facilitate international consortium, industry and investigator-initiated clinical trials in a dynamic and fast-paced oncology setting.

In this role you will work collaboratively with many internal and external partners and stakeholders including physicians, nurses, pharmaceutical companies, CROs, other departments within the hospital (i.e. the Research Institute, REB, Grants Management Office, pharmacy, laboratory services, diagnostic imaging, etc.) as well as other CTSU team members including budget and contract associates, project coordinators and other project managers. You will be responsible for initiating, planning and coordinating clinical trials studies from start up to close out.

Don't miss out on the opportunity to be part of a great team and work alongside the world's best in paediatric healthcare

Here's What You'll Get To Do:

Project management of trials from start-up to close-out, with a main focus in trial activation; ensure milestones and deliverables of all clinical trials in the program are achieved.
Work collaboratively with the Principal Investigator and other team members to oversee and manage all aspects of a clinical trial, including timely and accurate completion of SRB, REB, and other regulatory submissions.
Providing oversight, training and support to clinical research project coordinators and assistants on the team. Provide help, training and leadership to more junior staff within the CTSU. Coach and mentor.
Responsible for ensuring that the trial timelines and requirements for all the clinical trials in the portfolio are met in accordance with study protocol, sponsor and regulatory requirements
Establish and maintain processes for effective management of clinical trials in the program and across CTSU.
Depending on expertise, works with CTSU manager and research investigators to identify strategic directions and priorities for CTSU, prioritizing research foci for the section/program in alignment with division's and CTSU's strategic plans.
Screen, consent patients and enroll eligible patients on study as per study protocol; and supervise and provide support to more junior team members
Monitor serious adverse events or reactions, and report to internal (REB), and external regulatory bodies'; notification of collaborators, and/or patients as necessary
Responsible for managing and tracking study budgets, working with the budget associate and PI
Working with the legal and contracts department within SickKids to ensure proper documents are in place
Collaborate with pharmacists, lab managers and other key stakeholders throughout the hospital
Build strong relationships with all stakeholders; maintaining positive relationships
Responsible for study data abstraction and submission in accordance with sponsor requirements and timelines, as/when needed
Participate in audits, site visits and monitoring by Health Canada, SickKids and other regulatory agencies
Develop and monitor timelines for existing studies, balancing the demands of multiple projects
Develop and maintain database of all current studies and their status; use project managements tools such a Clinical Trials Management Systems and PM tools (i.e. Asana) for report generating
Provide working knowledge and experience of international laws and regulations
Help develop and maintain standard operating procedures (SOPs) and contribute to the ongoing standardization and improvement of processes within the division and at the hospital level
Participate in educational initiatives concerning clinical trials and attend related meetings
Contribute to other areas and functions of the team, as necessary. Support CTSU manager with