Clinical Research Project Manager

4 months ago

Toronto, Canada SickKids Full time

**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**:
**CTSU Clinical Research Project Manager**

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**:

- Manage trials from start-up to close-out, in collaboration with Principal Investigator (PI), other stakeholders and team members.
- Responsible for ensuring that the trial milestones and timelines and requirements for all the clinical trials in the portfolio are met in accordance with study protocol, sponsor, and regulatory requirements.
- Accountable for ensuring milestones and deliverables of all clinical trials in the program are achieved.
- Providing oversight, training and support to junior team members and new hires, including clinical research project coordinators and assistants, students, interns etc..
- Contribute to establishing and maintaining processes for effective management of clinical trials in the program and across CTSU.
- Screen, consent and enroll eligible patients on study as per study protocol; and/or supervise and support junior team members with all aspects of research patient management.
- Responsible for ensuring strict monitoring of Serious Adverse Events or Reactions, and timely reporting/notification to internal (REB, Privacy Office etc.), and external regulatory bodies, collaborators and patients as required.
- Responsible for managing and tracking study budgets and agreements, in collaboration with the contract/budget associate, legal office, and PI.
- Collaborate with pharmacists, lab managers and other key services, departments, and stakeholders throughout the hospital.
- Build and maintain strong and positive relationships with all stakeholders.
- Responsible for performing and/or overseeing study data abstraction and data reporting/submission in accordance with study protocols, agreements, and all applicable guidelines.
- Participate and contribute to planning and conduct of audits, inspections, site visits and monitoring by internal and external regulatory agencies such as Health Canada, FDA, consortia, Sponsors etc.
- Develop and monitor timelines for existing studies, balancing the demands of multiple projects
- Develop and maintain databases and trackers of all current studies as needed; use existing and new project managements tools such a Clinical Trials Management Systems and PM tools (i.e., Asana) for report generating.
- Maintain 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 recruitment and training of new staff.
- Work with Program Managers, CTSU manager and research investigators to identify strategic directions

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