Manager, Clinical Trials Unit - Research Operations, Services and Support

CAMH

  • Toronto, ON
  • Permanent
  • Full-time
  • 1 day ago
Through its core values of Courage, Respect and Excellence, CAMH is implementing its Strategic Plan: Connected CAMH, to transform lives, ignite innovation and discovery, revolutionize education and drive social change. CAMH is more than a hospital, it is a cause. CAMH is on a mission to change the way society thinks about and responds to mental illness. They aim to eliminate prejudice and discrimination and shape a world where mental illness is central to our healthcare system - a world where Mental Health is Health.To learn more about CAMH, please visit their website at:To view our Land Acknowledgment, please clickThe Centre for Addiction and Mental Health (CAMH) Research Operations, Services and Support office is seeking a Manager, Clinical Trials Unit (CTU) 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.Job Description: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.Key Accountabilities:
  • 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.
The successful candidate will possess a Master's Degree in science, healthcare administration or an equivalent combination of academic training and work experience. A post-graduate certificate in Clinical Research and/or certification as a Clinical Research Professional (SOCRA/ACRP) is an asset. A minimum of five (5) years of related experience in a Health Canada regulated clinical research role within an academic research hospital or the pharmaceutical environment is required. Highly developed expertise in understanding and reviewing clinical trial protocols is required, as well as a strong understanding of site activation processes to support study start up timelines. The candidate must possess demonstrated understanding of regulatory guidelines & research governance of human participant research (ICH GCP, TCPS2, Health Canada regulations, FDA, etc.). Strong time management and organizational skills are required. Ability to provide leadership and facilitate change management through influence, innovative practices and teaching skills, to foster a culture of responsiveness, compliance awareness, self-regulation, quality system ownership, and continuous improvement, in order to achieve rigour and efficiency of high-risk clinical research. You possess sound judgment, negotiation, conflict management, strategic planning, and advanced facilitation and teamwork skills. Problem solving, networking and partnership building skills are also required. You possess excellent written and verbal communication skills and the ability to explain complex issues in plain language, both verbally and in writing. You have advanced computer skills in a Microsoft office environment. Candidates require the ability to work effectively with individuals from diverse backgrounds. Previous management experience is an asset.Please note: This full-time, permanent position is NOT part of any bargaining unit.Salary range: Competitive salary and benefits package.CAMH is a fully affiliated teaching hospital and research institute of the University of Toronto. As a CAMH employee, you will contribute to our mission by supporting teaching, research, and clinical care across the hospital.CAMH is dedicated to equity, diversity, and inclusion. Our commitment is to foster a workplace, teaching, and learning environment that is inclusive, respectful, and free from discrimination or harassment.CAMH strongly encourages applications from candidates who reflect the diversity of the communities we serve, including First Nations, Métis, and Inuit Peoples; Black and other racialized communities; LGBTQ2S+ communities; women; and people with disabilities, including those with lived experience of mental health and substance use challenges.We welcome applicants from all backgrounds. Thank you to all who apply; however, only those selected for an interview will be contacted. If you require accommodations during the application or recruitment process, please let us know.

CAMH