Clinical Research Project Manager - RI

SickKids; Toronto; On-site; CAD 70,000 - 110,000; Full time

Job summary

An established industry player seeks a Clinical Research Project Manager to lead diverse clinical research initiatives. This pivotal role involves collaborating with clinical teams, developing research protocols, and ensuring compliance with health regulations. You will have the opportunity to significantly contribute to innovative therapeutic research while managing multiple concurrent studies. The position offers a chance to make a real impact on children's health and well-being, alongside a supportive and inclusive work environment that values diversity. Join a team dedicated to improving health outcomes and shaping the future of pediatric care.

Benefits

Health and Dental Benefits

Employee Benefits Coverage

Impactful Work

Support for Diversity and Inclusion

Qualifications

• Master's degree in Health Science with 3+ years in clinical research.
• Strong organizational and communication skills are essential.

Responsibilities

• Manage clinical research projects from startup to closeout.
• Develop protocols, case report forms, and ensure regulatory compliance.
• Supervise research coordinators and maintain study budgets.

Skills

Organizational Skills

Effective Communication

Knowledge of Clinical Research Regulations

Equity, Diversity, and Inclusion Commitment

Education

Master's degree in Health Science

Tools

Database Management Software

Job description

Position Description

The Clinical Research Project Manager works closely with the Senior Manager, Clinical Research Facilities and Services, Principal Investigators, and clinical research staff to plan and manage a diverse clinical research program. This includes study startup, maintenance, and closeout of multiple concurrent studies. The manager will be responsible for activities of the Clinical Research Coordinator Services team, comprised of clinical research coordinators and assistants, including on-going training and supervision, contributing to performance appraisals, organizing team meetings and communication strategies. The Manager will develop close working relationships with SickKids and affiliated medical and health care professional staff who provide clinical care to the study participants. The Project manager may also assume Clinical Research Coordinator responsibilities. Also, the Clinical Research Project Manager will report to the Senior Manager, Clinical Research Facilities and Services, Clinical Research Operations.

The Clinical Research Program Manager will work closely with clinical coordinators, SickKids Clinical Research Centre nurses, SickKids Central Biobank research technologists, SickKids clinical research teams and clinician scientists, affiliated institutes, and collaborative networks. The successful candidate will have the opportunity to contribute to research into new therapeutic agents, improve standard of care best practices, and build experience managing a diversity of trials.

Here's What You'll Get to Do

• Collaborate with the Senior Manager and/or Principal Investigator(s) on new research study protocols, status reports and presentations.
• Prepare and contribute to research protocol development, liaising with study teams.
• Develop case report forms, questionnaires, and informed consent documents based on templates, regulations, and institutional requirements.
• Develop and submit applications and amendments to the REB; follow up on queries and changes.
• Develop policies and Standard Operating Procedures related to the conduct and execution of the research program, training and regulatory compliance to regulations, clinical best practice guidelines and SickKids policies. Assist with training of staff.
• Maintain and monitor study timelines and team progress throughout study startup, maintenance, and closeout, balancing the demands of multiple projects. Develop and maintain a database of current studies and their status.
• Develop and maintain study binders and/or electronic trial master file(s) of the clinical program and monitor compliance.
• Participate in audits, site visits and monitoring by SickKids and other regulatory bodies.
• Supervise database development, entry, and cleaning/lock. As required, develop programming to produce regular database reports, with Senior Manager, Principal Investigator and/or Data Analyst.
• Manage the overall study, in multi-centre trials, including participation in selection, training, monitoring and ongoing communication with other sites, and organize Investigator meetings.
• Monitor serious adverse events or drug reactions, and report to Principal Investigator. Follow-up on adverse events, including filing reports with internal and external regulatory bodies (REB), notification of collaborators, and/or patients.
• Oversee recruitment and participant contacts.
• Develop, manage, and maintain study budgets.
• Monitor staff performance and assist Senior Manager with annual performance appraisals.

Here's What You'll Need:

• A Master's degree in a Health Science related field, with a minimum of three years experience in clinical research.
• Strong organizational skills and the ability to communicate effectively are required to motivate the team and manage multiple concurrent studies.
• Strong knowledge of regulations and policies governing clinical research (e.g., Tri-council Policy Statement, ICH Guidelines, Good Clinical Practices, and Health Canada and FDA regulations)
• Demonstrated commitment and actions in advancing equity, diversity, and inclusion objectives.

Assets:

• A post-graduate clinical diploma or certification by the Society of Clinical Research Associates (SOCRA) as a Certified Clinical Research Professional (CCRP) is an asset.

Here's What You'll Love:

• 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.
• 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: Full-time, Permanent.

Our Commitment to Diversity

The children and families we care for are from a variety of communities, and so are our employees. We welcome and encourage everyone to join our organization and be part of our team.

When requested, SickKids will provide access and inclusion supports to eligible candidates to support their full engagement during the interview and assessment process. Information received related to access or inclusion will be addressed confidentially.

Thank you for your interest in joining SickKids. Only those applicants selected for an interview will be contacted. In accordance with our Hospital policy, employment at SickKids is conditional upon the Hospital’s receipt of all necessary documentation.

How to Apply:

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