Clinical Trials Manager

6 days ago

Hamilton, Canada McMaster University Full time

**Schedule**
8:30 - 4:30; Monday -Friday, 35 hours/week

**Education Level**
Masters degree or equivent training in clinical trial management and/or health related research methodology

**Career Level**
5 years supervisory or management experience in clinical trials management

**About McMaster University**

Ranked as one of the world’s top 70 universities, McMaster University is known for teaching and research excellence. Our purpose is the discovery, communication, and preservation of knowledge. We seek to create a Brighter World through research, focussed on the health and well-being of all. Through our teaching, research, and scholarship, we are committed to creativity, innovation, and excellence. We value integrity, quality, inclusiveness, and teamwork in everything we do. We inspire critical thinking, personal growth, and a passion for lifelong learning. We serve the social, cultural, and economic needs of our community and our society.

**About the Department of Surgery**

Over its 50+ year history, the McMaster Department of Surgery has maintained a steadfast commitment towards thinking big and making it possible.

We are a department with 11 surgical divisions and Royal College residency training programs; together, we are poised to unleash a future fueled by a creative mindset and powered by our people.

**CREATE**

We commit to an inclusive **Culture**

**Research** that impacts

**Education** that inspires

**Advancement** for all

**Transformation** through innovation

**Excellence** in patient care

**New Leadership Opportunity**

The Department of Surgery, in the Faculty of Health Sciences is seeking a Clinical Trials Manager to join the Surgical Methods Centre research team. This busy and productive group conducts b orthopaedic surgical trials with the goal of improving outcomes for patients who experience musculoskeletal injuries.

Working closely with the Research Manager, Research Director, and Principal Investigators, the Clinical Trials Manager will play a vital role in the development, implementation, monitoring, and evaluation of one or more international orthopaedic surgical clinical trials. Key aspects of this position will include strategic planning, securing and managing research funding, daily supervision of research personnel, maintaining compliance with guidelines and regulations for the conduct of clinical trials (e.g. Heath Canada and US FDA), as well as fostering and maintaining relationships with funding partners, international collaborators, and other stakeholders.

**Core Accountabilities**:
In a collaborative team environment, which embraces the values of integrity, teamwork and inclusivity, the Manager, Clinical Trials manager will serve as a leader and is accountable for the following:

- With direction from the Principal Investigators and Research Management, oversees all daily activities associated with one or more multi-centre clinical trials in surgery. This includes all phases of the clinical trial lifecycle from planning and start-up, through recruitment and follow-up, to trial close-out and knowledge translation.
- Collaborates with Research Manager and Principal Investigators to develop large-scale multi-institutional, multi-sector international funding proposals. Develops budget and resource justifications, timelines and deliverables, as well as governance plans, collaboration plans, training and mentorship plans, patient engagement plans and knowledge translation/dissemination plans.
- Responsible for managing clinical trial funding, which may include industry funding, internal institutional funding, and government/agency funding.
- Develops and maintains individual clinical trial budgets. Creates financial projections and makes adjustments to clinical trial budgets throughout the fiscal year.
- 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 and Research Management team, 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. US FDA and Health Canada).
- In collaboration with the Principal Investigator and Research Management team, develops project milestones, management plans, as well as other required operational documentation.
- Responsible for identifying risks, troubleshooting research challenges and developing and implementing mitigation strategies in the conduct of clinical trials.
- Writes scientific and financial progress reports.
- Writes sections of regulatory submissions (e.g. Health Canada, US

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