Clinical Research Project Manager

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

Clinical Research Project Manager-CTSU

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.

We are currently seeking a Clinical Research Project Manager to join the Neuro-Oncology Program within the Clinical Trials Support Unit (CTSU), part of the Haematology/Oncology portfolio. This is an exciting opportunity to apply your project management expertise and clinical trial knowledge to support international consortium, industry-sponsored, and investigator-initiated trials in a dynamic and specialized neuro-oncology setting.

In this role, you will collaborate with a wide range of internal and external partners, including physicians, nurses, pharmaceutical companies, CROs, and key hospital departments (e.g., Research Institute, REB, Grants Management Office, pharmacy, laboratory services, and diagnostic imaging). You will also work closely with CTSU team members, including budget and contract associates, project coordinators, and fellow project managers within the Neuro-Oncology program. You will be responsible for the initiation, planning, and coordination of clinical trials from start-up through to close-out.

This is a unique opportunity to contribute to cutting-edge neuro-oncology research while working alongside a highly skilled and collaborative team 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.
Responsible for completing and/or supporting/overseeing all trial start-up activities and trial activation, including but not limited to, timely and accurate completion and submission of SRB, REB, Health Canada and other regulatory applications
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 and priorities for section and CTSU, prioritize resource allocation for the section/program in alignment with the strategic plans of the division and CTSU.
Here's What You'll Need

Essential Requirements

Baccalaureate degree in a related discipline required
5+ years' experience in interventional clinical trials management is required
Knowledge of oncology clinical research
Experience managing multiple, complex early phase, industry-funded or consortium clinical trials
Experience with creating & managing budgets and helping to facilitate contract execution
Excellent organizational and analytic skills; ability to work on multiple projects simultaneously
Excellent computer skills; knowledge of electronic health records and EDCs
Self-motivated, self-directed, and able to work both independently and within a team
Be able to manage a high workload with multiple conflicting priorities at the same time
Exceptional people management and mentoring skills. Ability to work well with others, fostering an engaging, inclusive, and positive work environment.
Exceptional interpersonal, leadership, critical thinking and communication skills
Superior knowledge of medical terminology, clinical trials, good clinical practice guidelines, Canadian and US regulatory compliance
Experience with national and/or international clinical trial administration is an asset
Assets

Master's degree or other graduate-level education.
CCRP (Certified Clinical Research Professional) certification will be an asset
PMP (Project Management Professional) certification an asset
Experience with national and/or international clinical trial administration

Here's What You'll Love

This position is eligible for employee benefits coverage and pension plan (HOOPP). The full benefits offered will be discussed at the time of position offer.
A focus on employee wellness with our Staff Health and Well-being Strategy. Self-care helps us support others.
A hospital that welcomes and focuses on Equity, Diversity, and Inclusion.
The opportunity to make an impact. Regardless of your role or professional interest, you will be making a difference at SickKids and contributing to our vision of Healthier Children. A Better World.
Employment Type

Permanent full time: 35-hour work week, hybrid option
Our Commitment to Diversity

SickKids is committed to championing equity, diversity and inclusion in all that we do, fostering an intentionally inclusive and culturally safe environment that reflects the diversity of the patients, families and communities we serve. Learn more about workplace inclusion.

Accessibility & Accommodation

If you require accommodation during the application process, please reach out to our aSKHR team. SickKids can provide access and inclusion supports to eligible candidates to support their full engagement during the interview and selection process as well as to ensure candidates are able to perform their duties once successfully hired. If you are invited for an interview and require accommodation, please let us know at the time of your invitation to interview. Information received related to access, inclusion or accommodation will be addressed confidentially.

How To Apply

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