Reference Number: 000002166
Posted Date: 6/24/2026
Closing Date: 7/15/2026

Department: LTRI
Position: Clinical Trials Manager

The Lunenfeld-Tanenbaum Research Institute of Mount Sinai Hospital, a University of Toronto affiliated research center, is one of the world's leading centers in biomedical research.  With ground-breaking discoveries in research areas such as diabetes, genetic disorders, cancer and women’s and infants’ health, the Institute is committed to excellence in health research and the training of young investigators.  Strong partnerships with the clinical programs of Mount Sinai Hospital ensure that scientific knowledge is used to promote human health.  Your significant contributions will assist in maintaining our momentum in advancing our research.

Job Summary

Working closely with a team of surgeons specializing in orthopaedic oncology and lower extremity reconstruction, research scientists, and research staff, the Clinical Trials Manager will play a vital role in the planning, management and oversight of a multi-site, multi-disciplinary clinical trials research program in musculoskeletal oncology, complex arthroplasty, and metastatic bone disease. Key aspects of this position will include strategic planning, securing and managing research funding, daily supervision of research personnel, maintaining compliance with guidance and regulations for the conduct of clinical trials (e.g., Health Canada and US FDA), as well as developing and fostering relationships with funding partners, international collaborators, research user groups and other stakeholders. However, the role may also include occasional patient-facing tasks (e.g., recruitment, consent, follow-up visits).

Key Responsibilities and Accountabilities

• With direction from the Principal Investigators, oversees all aspects associated with the orthopaedic clinical trials research program (including daily oversight of one or more multi-centre orthopaedic clinical trials).
• Makes significant contributions to the development of clinical trials within the research program, from planning and start-up, through recruitment and follow-up, to trial close-out and knowledge translation.
• Develops inter-disciplinary, inter-institutional and inter-sectoral research collaborations and partnerships.
• Develops, in collaboration with Principal Investigators, and submits large-scale multi-institutional, multi-sector international funding proposals.
• Develops and maintains individual clinical trial budgets. Creates financial projections and makes adjustments to clinical trial budgets throughout the fiscal year.
• Manages clinical trial funding, which may include industry funding, internal institutional funding, and government/agency funding.
• Leads the development and authoring of research protocols.
• With support from the Research Management team, is responsible for ensuring the appropriate infrastructure is in place to support the research program.
• Negotiates research agreements and subcontracts to meet site and coordinating centre requirements.
• Provides daily supervision to research personnel assigned to one or more clinical trial teams.
• Plans, monitors and oversees clinical trials to meet data management, scientific and regulatory requirements recognizing that needs will differ among funding agencies and sponsors.
• In collaboration with Principal Investigators, ensures that clinical trials are conducted in accordance with local standard operating procedures (SOPs) and policies, clinical trial agreements, funder guidelines, as well as with national and international regulatory requirements (e.g., Health Canada and US FDA).
• In collaboration with the Principal Investigators, develops project milestones, management plans, as well as other required operational documentation.
• Identifies risks, troubleshooting challenges at all stages of project/program development and implementation, and developing and implementing mitigation strategies in the conduct of clinical trials.
• Designs promotional strategies and related materials to encourage participation and support for research program.
• Coordinates and manages the collection, delivery, entry, verification, analysis and reporting of data.
• Supports biospecimen collection where required
• Oversees the design and development of data management systems.
• Oversees the analysis and interpretation of data.
• Writes scientific and financial progress reports.
• Writes sections of regulatory submissions (e.g. Health Canada, US FDA).
• Authors scientific manuscripts and prepares papers and presentations for investigator meetings, seminars and conferences.
• Identifies opportunities for quality improvements and enhanced regulatory compliance.
• Stays up-to-date in current advances by reading relevant literature and attending conferences and professional training courses.
• Keeps up-to-date with the guidelines and regulations imposed by regulatory agencies as they relate to the conduct of clinical trials.
• Travels to national and international conferences and clinical sites to foster collaborations, participate in clinical trial meetings and conduct site training/monitoring visits.
• Responsible for human resources activities for the clinical trial research teams, ensuring compliance with all Human Resource policies and procedures while maintaining professionalism and confidentiality.
• Evaluates the needs of the clinical trial research teams and makes recommendations regarding allocation of resources, and training/development for research personnel.
• Responsible for recruitment and training of research personnel, assigning work, and making recommendations for improvements to workflow within the clinical trial research team.
• Responsible for Health and Safety oversight, scheduling vacation, facilitating retention, and supporting career development for clinical trial research team members.
• Conducts probation meetings and performance evaluations.

Qualifications and Skills

Education

• Bachelor’s degree in a health-related field or equivalent experience

Experience

• Ten (10) years previous experience in clinical trial management including experience with managing trials subject to oversight by regulatory authorities (e.g.. Health Canada, US FDA). Experience in oncology, orthopaedics, or arthroplasty research is an asset.
•  Demonstrated history of progressively greater responsibilities in clinical trial management, including at least five (5) years managing large, multi-centre regulated clinical trials
• Experience in supervising research personnel is required

Knowledge/Skills

• In-depth expertise in the management of clinical trials (e.g., regulatory oversight; project management; critical thinking and research appraisal skills; knowledge and application of clinical trials methodology).
• Independent thinking, intellectual vigour, and a mix of entrepreneurship, innovation and management rigour.
• Strong communication, documentation, and interpersonal skills
• Proficient with Microsoft Office; REDCap/EDC experience preferred
• Familiarity with musculoskeletal anatomy and surgical terminology an asset
• Excellent organization and time management across multiple studies
• Ability to work independently and within a multidisciplinary team
• Ability to effectively supervise, train and mentor others
• Ability to interact effectively with a diverse range of senior level stakeholders
• Strong knowledge of ICH-GCP guidelines, TCPS2, N2 SOPs, and Health Canada/US FDA regulations on the conduct of clinical trials is required.
• Strong scientific and business writing skills for the development of funding proposals is required.

Salary range: $93,490 to $102,880

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. All employees and affiliates will follow safe work practices and comply with health and safety policies, procedures, and training. 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.

Hours: 37.5 hours per week

Contact Name: Online