SickKids’ Clinical Research Operations (CR Ops) is seeking a dynamic and highly motivated Senior Manager, Regulatory and Compliance with extensive experience and expertise in clinical trials management, regulatory and trial sponsor oversight. As SickKids embarks on a transformative journey in support of Precision Child Health (PCH), we are dedicated to building a robust Regulatory and Compliance Office (RCO) 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 SickKids’ Clinical Research Operations (CR Ops) is seeking a dynamic and highly motivated Senior Manager, Regulatory and Compliance with extensive experience and expertise in clinical trials management, regulatory and trial sponsor oversight. As SickKids embarks on a transformative journey in support of Precision Child Health (PCH), we are dedicated to building a robust Regulatory and Compliance Office (RCO) 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.
In this pivotal role, the Senior Manager, Regulatory and Compliance will report to the Director of Clinical Research Operations Transformation. Their primary responsibility will be to transform and enhance the sponsor oversight functions for SickKids-sponsored investigator-initiated clinical trials. They will manage a team of regulatory compliance specialists, quality assurance specialists, audit and compliance lead, IIT study project managers etc. who work closely with study teams, ethics team and other functions across Research Operations to ensure the set up, conduct and oversight of IITs at SickKids meet the highest standards of quality and compliance with national and international regulatory guidelines, regulations and Good Clinical Practices. As part of the broader Clinical Research Transformation at SickKids, they will also serve as the regulatory subject matter expert to support the development of relevant clinical research programs, infrastructure, processes, and policies relating to interventional clinical trials undertaken at SickKids.
To excel in this position, the Senior Manager, Regulatory and Compliance must have clinical trials management experience and possess in-depth knowledge of regulations, guidelines, and best practices governing regulated clinical trials, along with a keen understanding of the evolving landscape of clinical research and the regulatory requirements for new drugs, medical devices, and gene therapy products, amongst others. They must also have extensive strategy building, change management, people and stakeholder management and other relevant business skills necessary to execute and drive change in a complex work environment.
Here’s What You’ll Get to Do:
Lead the redevelopment and expansion of the regulatory, quality assurance and sponsor oversight functions for investigator-initiated clinical trials at SickKids
Participate in various Clinical Research Transformation initiatives and lead implementation of projects relevant to the Regulatory and Compliance Office
Set the strategic direction for the team and lead the quality assurance team in the development and implementation of new operating models, workflows, SOPs, processes and policies related to overall conduct, management and oversight of IITs at SickKids
Build and manage a team of highly trained staff with expertise in management of regulated clinical trials who can perform all regulatory and GCP requirements for sponsor oversight of IITs, from pre-grant submission, to trial set up, to site initiation all the way to closure and archiving
Oversee the education and training team to ensure strategic development and dissemination of clinical research courses and training materials
Update and oversee the Quality Management Program for Health Canada-regulated IITs at SickKids, as a framework for all quality management activities for IITs, including but not limited to quality control, quality assurance, and quality improvement work
In collaboration with Risk and Compliance team, develop a clinical research audit program for SickKids
Lead the implementation of processes and technology solutions to help track and report on risk exposures and issue trends for IITs; proactively identify areas where risk mitigation strategies are needed; and escalate to senior leadership as needed
Identify opportunities for process improvement and optimization, leading initiatives to enhance efficiency and effectiveness in regulatory affairs and IIT management
Point of contact for complex consultations or engagements with Health Canada, such as regulatory inspections
Provide leadership and direction to staff including, coaching, advising, mentoring and communicating and educating staff to ensure a complete understanding of business and department strategy, programs and related legislation. Responsible for the recruitment, performance management, and development of staff
Represent SickKids on relevant committees and through presentations, where appropriate
Perform other related duties as assigned by Director and other senior leaders
Here’s What You’ll Need:
Essential Requirements
A minimum of a Bachelor’s degree or equivalent in a research, health sciences, life sciences or related field required
A minimum of 7+ years experience in clinical research is required, including a combination of the following: 3+ years of experience coordinating and managing clinical trials, and/or 3+ years of clinical trial management experience, and/or 3+ years of experience in clinical trial quality assurance, and/or 2+ years of experience in regulatory affairs within the academic research, biotechnology or pharmaceutical environments, and/or 3+ years of people management experience
Knowledge of Health Canada and FDA regulations, Tri-Council Policy Statement (TCPS2) and ICH GCP is required
Excellent organizational, communication, time management, problem-solving and interpersonal skills, high degree of accuracy and attention to detail
Strong analytical skills with the ability to assess complex regulatory issues and develop strategic solutions
Strong written, verbal, and analytical skills and the ability to manage multiple activities simultaneously
Demonstrated initiative, excellent use of judgment and discretion
Excellent people skills and stakeholder management skills
Strong computer software skills and advanced skills in Microsoft Office programs
Demonstrated commitment and actions in advancing equity, diversity, and inclusion objectives
Assets
Advanced degree in Health Sciences, Health Care Administration, or another related field is an asset
Current Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals certification (ACRP) is a strong asset
Pharmaceutical/biotechnology industry experience is an asset
Experience with leading or supporting audits and inspection activities is an asset
Here’s What You’ll Love:
Benefits
This position is eligible for employee benefits coverage; including but not limited to, health and dental benefits. The benefits offered will be discussed at the time of position offer.
A focus on employee wellness with our new Staff Health and Well-being Strategy. Self-care helps us support others.
Impact
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:
35-hour work week, permanent full time role
Hybrid (Onsite and Remote) Work Model – necessary technology provided for remote work