| POSITION TITLE |
Manager, Clinical Trials Start-up & Quality |
| DEPARTMENT |
Clinical Research Hub, Sinai Health |
| EMPLOYMENT TYPE |
Regular Full-time |
| HOURS OF WORK |
37.5 hours per week |
| EMPLOYEE GROUP |
Non-Union |
| REPORTS TO |
Director, Clinical Research Operations & Research Compliance |
Manager, Clinical Trials Start-up & Quality
Clinical Research Hub, Sinai Health
Position Summary
Reporting to the Director, Clinical Research Operations & Research Compliance, the Manager provides specialized clinical research and trials expertise within the Clinical Research Hub (CRHub). The role supports clinical trial start-up and activation, including Clinical Trials Ontario (CTO) and QuickSTART processes, coordination of institutional biosafety/IBC review requirements for clinical trials, research budget development, and clinical research quality, monitoring and audit activities.
The Manager also serves as a central point of contact for complex, multisite and industry-sponsored studies, helping research teams navigate institutional requirements and ensuring that the appropriate Research Administration units, institutional subject-matter experts and other services are engaged at the right stage of the research lifecycle. The Manager owns these files at the operational level and escalates matters requiring institutional decision, delegated approval or compliance action to the Director.
Key Responsibilities
Clinical Trial Start-up & Multisite Research
- Oversee clinical trial start-up and activation, including CTO and QuickSTART processes for studies where Sinai Health participates as a site.
- Review study submissions and start-up requirements for institutional impact, completeness, budget and other Sinai Health requirements, coordinating with relevant institutional units as needed.
- Maintain oversight of study start-up milestones and outstanding requirements, identify barriers or delays and support their timely resolution.
- Serve as a key operational contact with investigators, study teams, sponsors/CROs and external partners on clinical trial start-up.
- Support implementation of streamlined, harmonized and reliance-based approaches to multisite research, including emerging TAHSN collaboration frameworks, and help integrate these approaches into Sinai Health processes.
Clinical Trial Biosafety/IBC Review
- Coordinate the institutional biosafety/IBC review pathway for clinical trials requiring biosafety review, working in partnership with institutional biosafety subject-matter experts and other relevant partners.
- Identify clinical trials requiring biosafety/IBC review and ensure that review is appropriately integrated into study start-up.
- Coordinate submissions, communication, decisions, conditions and follow-up among investigators, study teams, IBC members and institutional partners.
- Maintain complete, accurate and audit-ready IBC records and support development of clinical-trial-facing workflows, guidance and tools.
Clinical Research Budgets
- Support development and review of protocol-informed budgets for clinical research studies, including complex and industry-sponsored trials.
- Review protocols and schedules of assessments to identify study procedures, institutional services and associated costs, including appropriate distinction between research-specific and standard-of-care costs.
- Work with Research Finance, Research Contracts, Grants Management and service departments to support accurate budgets, appropriate cost recovery and alignment between protocols, budgets and agreements.
- Identify budget, resource and cost-recovery issues early and facilitate resolution with relevant stakeholders.
Complex Study Support & Research Administration Partnership
- Serve as a central resource and first-line case manager for complex clinical research studies requiring coordination across multiple Research Administration and institutional units.
- Review proposed studies for institutional and operational feasibility, identifying requirements, dependencies, resource implications, risks and potential barriers, and help research teams understand what is required to initiate and conduct their studies.
- Coordinate cross-functional discussions and provide practical guidance to investigators and study teams on complex, multisite and regulated clinical research.
- Escalate matters requiring institutional decision, delegated authority, significant risk assessment or senior resolution to the Director or appropriate institutional leader.
- Identify recurring barriers, process gaps and opportunities to improve research activation and the researcher experience.
Clinical Research Quality, Monitoring and Audit
- Lead day-to-day implementation of the CRHub's clinical research quality, monitoring and internal audit activities under the direction of the Director.
- Conduct risk-based monitoring, quality reviews and internal audits in collaboration with the REB Office and other institutional partners as appropriate.
- Support research teams in preparing for sponsor, CRO, regulatory and institutional audits and inspections.
Education and Training
- Develop and deliver clinical research education and training in the Manager's areas of expertise (e.g., CTO, study budgets, GCP, monitoring and audit readiness), aligned with the CRHub education plan set by the Director, including practical materials, guidance documents, templates and tools.
- Support planning and delivery of training seminars and workshops on clinical research requirements, quality, regulatory compliance and institutional processes, informed by needs identified through CTO activity, biosafety review, monitoring and audits.
CRHub Operations & Director Support
- Support the Director in advancing CRHub priorities, strategic initiatives and continuous improvement, including leading assigned projects and process-improvement initiatives.
- Operate the Departmental Impact Evaluation Request (DIER) process for clinical studies under the Director's leadership, coordinating review with affected departments and institutional partners.
- Develop and monitor service, quality and risk metrics for the Manager's portfolio and contribute to CRHub scorecards, reporting and the clinical research risk register.
- Develop substantive SOPs, workflows, guidance, templates and researcher-facing resources within the Manager's areas of responsibility, working with CRHub administrative staff to support publication and maintenance.
- Support non-compliance reviews and other complex or escalated matters as assigned by the Director, including fact-finding, documentation and follow-up.
- Represent the CRHub on relevant institutional and external committees and working groups, and work collaboratively with other CRHub staff and Research Administration partners to support coordinated service delivery.
Qualifications
Experience & Knowledge
- Undergraduate degree in a relevant field (e.g., life sciences, health sciences, health administration, regulatory affairs) or an equivalent combination of education and experience; an advanced degree is an asset.
- 5+ years of progressively responsible experience in clinical research, clinical trials or clinical research administration, ideally within an academic hospital, academic health sciences centre or similarly complex environment.
- Strong practical experience in the start-up and conduct of interventional clinical trials, including experience with complex, multisite, industry-sponsored and/or Health Canada-regulated studies.
- Demonstrated ability to review protocols and study requirements and identify operational, institutional, regulatory and budget implications, including experience developing or reviewing clinical trial budgets and distinguishing research-specific from standard-of-care costs.
- Experience with clinical research quality, monitoring, audit and/or regulatory compliance, with an understanding of good documentation practices, audit readiness and corrective and preventive action.
- Strong working knowledge of the Canadian clinical research environment, including ICH-GCP, Health Canada requirements, TCPS 2 and institutional research approval processes.
- Demonstrated ability to manage complex projects or portfolios, coordinate across multiple stakeholders and organizational units, and move work forward in environments where responsibilities are shared.
- Experience developing practical processes, guidance, tools or training to support clinical research teams.
Assets
Experience with one or more of the following would be considered an asset: Clinical Trials Ontario (CTO) and QuickSTART or comparable multisite clinical research processes; harmonized, reliance-based or streamlined research activation pathways; clinical-trial biosafety/IBC review pathways; research ethics and quality-assurance inspections; clinical trial agreements and cost-recovery models; grant-funded multisite studies; and clinical research systems such as REDCap, CTMS or Epic. Relevant professional certification (e.g., ACRP or SoCRA) is also an asset.
Skills & Attributes
- Excellent relationship-building, communication and writing skills, with the ability to explain complex clinical research requirements clearly and practically.
- Strong judgment and a practical, solutions-oriented approach, including knowing when an issue requires additional expertise, escalation or institutional decision-making.
- Ability to work effectively across organizational boundaries and influence outcomes through collaboration rather than formal authority.
- Strong analytical, project-management and organizational skills, with the ability to independently manage multiple complex files and anticipate downstream requirements.
- Demonstrated initiative, accountability, attention to detail and commitment to quality in a complex and evolving environment.
SALARY:
Applications should include the following documents:
- A cover letter
- A curriculum vitae
- Three references
Applications should be submitted via the Interfolio website https://apply.interfolio.com/195557 by October 31, 2026.
Note that e-mailed applications will not be accepted.
In accordance with Institute’s policy and legislated health and safety requirements, employment is conditional upon the verification of credentials, completion of a health review, and demonstrating proof of immunity and vaccination status of vaccine-preventable diseases. Successful candidates will be required to provide two (2) written reference letters from their former employer(s)/supervisor(s).
We are a fully committed to fairness and equity in employment and our recruitment and selection practices. We encourage applications from Indigenous peoples, people with disabilities, members of sexual minority groups, members of racialized groups, women and any others who may contribute to the further diversification of our Sinai Health community. Accommodation will be provided in all parts of the hiring process as required under our Access for People with Disabilities policy. Applicants need to make their requirements known in advance.
The Lunenfeld-Tanenbaum Research Institute is a scent sensitive environment, and all members of the community are expected to refrain from wearing or using scented products while visiting or working at the Institute. We also support a barrier-free workplace supported by the Institute’s accessibility plan, accommodation and disability management policies and procedures. Should you require accommodation at any point during the recruitment process, including accessible job postings, please contact the Lunenfeld-Tanenbaum Human Resources Department.
Our hiring process uses job posting portals that screen relevant keywords, followed by a review from a human recruiter.
| Posting open until October 31, 2026. We thank all candidates for applying. Only those selected for an interview will be contacted. |
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