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

SickKids Regulatory and Compliance Office, within Clinical Research Operations, is seeking a dynamic and highly motivated Clinical Research Project Manager, Sponsor Oversight with extensive experience, and expertise in clinical trials management and sponsor oversight activities. As SickKids embarks on a transformative journey in support of Precision Child Health (PCH), we are dedicated to building a robust Regulatory and Compliance program at SickKids to ensure comprehensive institutional support and oversight of investigator-initiated clinical trials and streamlined processes, and standardized SOPs for conducting innovative, high-quality, and safe clinical trials.
One of the functions of the Regulatory and Compliance team is to support study teams across the institution to set up SickKids-sponsored (investigator-initiated) clinical trials. We are seeking a Clinical Research Project Manager to manage the clinical trials set-up activities for these trials from a sponsor¿s perspective.
One of the key roles of the Regulatory and Compliance team is to assist study teams throughout the institution in establishing SickKids-sponsored (investigator-initiated) clinical trials. We are currently seeking a Clinical Research Project Manager to oversee the set-up activities for these trials from the sponsor¿s perspective.

• As the sponsor representative, work with the investigators to oversee study start up research activities for investigator-initiated clinical trials (up to study initiation phase) to ensure compliance with institutional policies and regulatory requirements.
• At the pre-award phase, support study PI/teams with their grant application planning and budget estimation, to ensure all relevant costs are included in the grant application.
• Work closely with the study investigator to develop the study protocol, and other study documents in compliance with institutional and applicable regulatory requirements.
• Lead or support investigator with the development of data management plan, and project management plan, including safety management plan.
• Provide sponsor oversight with the development of a data management plan, database set up and UAT documentation.
• Develop Trial Master File (TMF) management plan, guide relevant team with the set and maintenance of sponsor study files relevant to SickKids.
• Ensure institutional process is followed for site selection process of multi-centred Investigator Initiated Trials (IITs).
• Coordinate meetings with study PI, Clinical Research Organizations (if involved) and other parties, to delineate and document sponsor responsibilities.
• Ensure that legal agreements, Statement of Work, and other relevant documents are in place for multi-site IITs prior to trial activation.
• Act as the sponsor contact for project, including study Principal Investigator, CRO, Legal team, Risk and Compliance, Research Pharmacy and other relevant parties.
• Provide guidance and ongoing sponsor support to all participating sites.
• Assist in preparing for regulatory inspections.
• Ensure all SickKids sponsor requirements are met before site activation.
• Contribute to the revision, development, implementation, and uptake of clinical research policies, SOPs, and other relevant resources relevant to IIT sponsor oversight activities, ensuring compliance with GCP, regulatory standards and best practices.
• Escalate issues, risks and opportunities to senior leadership, as needed.
• Perform other sponsor roles and responsibilities for assigned trials as needed.
• Represent SickKids on relevant committees and through presentations, where appropriate.
• Perform other related duties as assigned by Sr. Manager, Regulatory and Compliance Office.