Manager - Clinical Trials - Research Operations Service & Support
About The Position
The Centre for Addiction and Mental Health (CAMH) Research Operations, Services and Support office is seeking a full-time, permanent Manager, Clinical Trials to bring leadership and expertise to regulated research in the areas of budget review and negotiation, review of clinical trial design, clinical trial activation, external site selection, vendor qualification, risk management, education and regulatory inspections. The CTU supports CAMH researchers in the conduct of clinical trials through an evolving and complex regulatory landscape by building on existing infrastructure and maximizing shared resources to ensure the effective conduct of clinical research. The CTU promotes the rapid and efficient conduct of clinical trials, supports the effective translation of research findings into clinical practice, and provides mentorship and support to researchers through protocol development and regulatory applications. Reporting to the Director, Research Practice & Policy, you will enhance CAMH’s capability and capacity for high quality clinical research by identifying, supporting, expanding and implementing opportunities for greater support, compliance, risk management, and dissemination of best practices and current information in the field of regulated research. You will provide guidance to the CAMH Research Institute, CTU team, researchers and their teams, to manage regulated clinical research activities across the CAMH research enterprise. You will review clinical trial budgets submitted to grant agencies, and you will develop and negotiate budgets with external study sponsors. You will lead and manage Sponsor-level responsibilities for all CAMH-sponsored regulated research and support the seamless initiation of externally sponsored clinical trials. You will identify, evaluate and mitigate risks through collaboration with Directors, Research teams, department managers and staff from clinical trial initiation, study conduct and closeout.
Requirements
- Leadership and expertise in regulated research
- Budget review and negotiation skills
- Clinical trial design review
- Clinical trial activation experience
- External site selection experience
- Vendor qualification experience
- Risk management skills
- Education and regulatory inspections knowledge
- Experience managing regulated clinical research activities
- Experience reviewing clinical trial budgets submitted to grant agencies
- Experience developing and negotiating budgets with external study sponsors
- Experience leading and managing Sponsor-level responsibilities for regulated research
- Experience supporting the initiation of externally sponsored clinical trials
- Experience identifying, evaluating, and mitigating risks
- Experience collaborating with Directors, Research teams, department managers and staff
- Experience in clinical trial initiation, study conduct, and closeout
- Knowledge of Good Clinical Practice (GCP)
- Experience in developing, implementing, administering, and documenting policies, procedures, and systems for regulated clinical research
- Experience supporting regulatory inspections
- Experience developing corrective and preventative actions (CAPA)
- Experience developing tools/templates for regulated research
- Experience providing consultation to researchers and research staff regarding research conduct and regulatory compliance
- Supervisory experience
Nice To Haves
- Experience with pharmaceutical drugs, controlled drugs and substances, radiopharmaceuticals, natural health products and medical devices
Responsibilities
- Lead, manage and oversee Sponsor-level responsibilities for all CAMH-sponsored, regulated clinical research.
- Prepare, negotiate, analyze and finalize budgets with external study sponsors to ensure appropriate budgeting of fees required by clinical research protocols.
- Perform robust protocol feasibility reviews to assess for regulatory compliance, documentation requirements, and identification of special resources or skill requirements (e.g. IV infusion, venipuncture, qualified therapists, equipment, drug preparation/storage, etc.).
- Conduct site qualification visits of external clinical research sites, and vendor qualification assessments of external service providers.
- Initiate and lead the procurement of protocol-required services by external vendors, as needed.
- Support Research Legal in the review of clinical trial agreements, as needed.
- Manage new business opportunities and collaborations between the CTU and external partners.
- Lead and participate in the ongoing development, implementation, administration and documentation of policies, procedures and systems to ensure that regulated clinical research (including pharmaceutical drugs, controlled drugs and substances, radiopharmaceuticals, natural health products and medical devices) is conducted, documented and reported in compliance with all applicable regulations, internal standards, and Good Clinical Practice (GCP).
- Initiate and cultivate collaborative and cross-functional relationships with key stakeholders and departments to ensure a system-wide approach to efficient and high-quality clinical research.
- Identify potential risks or gaps with regulated clinical research at CAMH and implement best practices to mitigate/reduce/eliminate risks.
- Support regulatory inspections – e.g. coordinating inspection, response management, development of corrective and preventative actions (CAPA), etc.
- Identify, develop, implement, and evaluate tools/templates for regulated research according to legislative, regulatory, industry or participant needs.
- Undertake special projects that support seamless implementation of best practices in regulated research.
- Provide individualized consultation to CAMH researchers and research staff regarding research conduct and regulatory compliance.
- Supervisory oversight of CTU staff.
- Support a workplace that embraces diversity, encourages teamwork and complies with all applicable regulatory and legislative requirements.
Benefits
- Full-time, permanent position
- Opportunity to lead and bring expertise to regulated research
- Support CAMH researchers in the conduct of clinical trials
- Contribute to the translation of research findings into clinical practice
- Provide mentorship and support to researchers
- Enhance CAMH’s capability and capacity for high quality clinical research
- Identify, support, expand and implement opportunities for greater support, compliance, risk management, and dissemination of best practices
- Provide guidance to the CAMH Research Institute, CTU team, researchers and their teams
- Manage new business opportunities and collaborations
- Cultivate collaborative and cross-functional relationships
- Support a workplace that embraces diversity, encourages teamwork and complies with all applicable regulatory and legislative requirements
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
