Manager, Clinical Trials Unit - Toronto, Canada - Centre for Addiction and Mental Health

Centre for Addiction and Mental Health

Verified Company

Toronto, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Job Number: 929563

Category:
Management

Positions Available: 1

Years Experience Required: 5

Location:
Toronto, Ontario

Posted Date:
Mar 11, 2024

EMPLOYMENT OPPORTUNITY

Manager, Clinical Trials Unit

Research Operations, Services & Support

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 Sponsorlevel responsibilities for all CAMHsponsored, 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.
Initiate and lead the procurement of protocolrequired 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 crossfunctional relationships with key stakeholders and departments to ensure a systemwide 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.

Qualifications

Vaccines (COVID-19 and others) are a requirement of the job unless you have an exemption on a medical ground pursuant to the Ontario Human Rights Code.

Please Note:
This full-time, permanent position is NOT part of any bargaining unit.

Salary Range:
Competitive salary and benefits package.

CAMH is a Tobacco-Free Organization.

CAMH is fully affiliated with the University of Toronto and is a teaching hospital and research institute. As a CAMH employee, you will be expected to actively support CAMH's teaching and research activities, in addition to supporting the clinical work of the hospital.

At CAMH, we strive to be an equitable and inclusive employer. Our commitment to equity is grounded in an institution-wide commitment to achieving a working, teaching, and learning environment that is free of discrimination and harassment.
**We thank all applicants for their interest, however, only those selected for an interview will be contacted. Please inform us if you require accommodations during the interview process.