Clinical Trial Manager

2 weeks ago

Toronto, Canada Cell Technologies Inc. Full time

**Job Description for Clinical Trial Manager**

**Key Responsibilities**:

- Coordination of the overall conduct of a clinical trial, including assisting in development of the clinical trial protocol and managing the organization, development and/or submission of protocol amendments, case report forms, informed consent forms, study tools and templates, training materials, SOPs, and other study documents as required.
- Management of electronic documentation, such as eTMF (electronic Trial Master File) and EDCS (Electronic Data Capture System), and Database troubleshooting.
- Manage, coordinate, and submit the protocol and future amendments to the research ethics board (REB), including annual renewals, and safety reports.
- Assist in the negotiation of site contracts and site budgets, in accordance with sponsor requirements and budget framework.
- Prepare training material and presentations to be used for site initiation. ongoing training support and other educational requirements. Support and train participating site staff (QI, Co-I, coordinators, and assistants) involved in clinical activities and maintain documentation tracking site training.
- Oversee site preparedness of ethics submissions as well as support with REB queries and ICF modifications.
- Oversee site preparedness of Regulatory Inspections
- Organize and participate in Investigator, DSMB, Steering Committee and Coordinator Meetings, regular teleconferences with the team to ensure alignment on trial status, priorities, and upcoming milestones.
- Ensure the implementation and timelines of study deliverables are consistent with project requirements and budget expectations, including liaising with other service providers to ensure their deliverables are also being achieved.
- Assist with development of safety reporting plan and DSMB terms of reference.
- Oversee DSMB safety reporting and presentation of individual and aggregate data including preparation of safety reports, scheduling of the DSMB calls and meetings, liaising between DSMB and sites for data requests, controlling the flow of data across multiple groups while maintaining patient confidentiality and working within regulatory guidelines.
- Process invoices from clinical sites or contract service providers.
- Assist in the generation of study budget and enrolment forecasts.
- Oversee the management of Clinical Supplies for sites. Oversee all aspects of released study product including storage, delivery, use by the clinical site, and regulatory documentation.

**Salary**: $35.00-$75.00 per hour

Expected hours: 35 - 45 per week

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (preferred)

Work Location: Hybrid remote in Toronto, ON M5R 1A8

  • Cardiovascular Clinical Trial Liaison

    7 days ago

    Toronto, Canada Syneos Health Clinical Full time

    **Overview** **Researched and relatable, science-driven and social, you’re an extroverted expert.** If there’s one thing your preparation in earning your advanced degree has taught you, it’s how to evolve your expertise rapidly and stay at the forefront of your field. Forging new relationships and establishing rapport with thought leaders comes...

  • Clinical Trial Manager

    5 days ago

    Toronto, Canada Vasomune Therapeutics Full time

    (Full-time; Actively Recruiting) **Position Location**:951 Mariners Island Blvd., San Mateo, CA, 94404 and 180 John St., Toronto, Ontario, M5T 1X5 **Position Reports To**:President & CEO **Position Description**: The Clinical Trial Manager is accountable for the day-to-day operations of assigned clinical trials, including start-up, conduct and close-out...

  • Clinical Trial Manager

    3 days ago

    Toronto, Canada Acorn Biolabs Full time

    **Role**: Director of Clinical Trials - ______________________________________ Acorn Biolabs is a personalized regenerative medicine company enabling individuals to leverage the power of their own cells in cosmetics, injury recovery and general health. First, we offer a cell preservation service. As we age, so do our cells; over time, they become more...

  • Clinical Trial Manager

    7 days ago

    Toronto, Canada Amgen Full time

    **HOW MIGHT YOU DEFY IMAGINATION?** You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology...

  • Clinical Trials Manager

    1 week ago

    Toronto, Canada Hi!Funjob Inc. Full time

    Knowledge of FDA regulations and ICH guidelines is required 5+ years of experience in the Clinical Research field Experience with medical devices is an asset Advance knowledge of the Canadian regulations and Good Clinical Practices (GCP) Due to business growth, we are looking for a highly motivated and highly skilled Clinical Research Trials Manager to...

  • Clinical Trial Manager

    3 weeks ago

    toronto, Canada ICON Strategic Solutions Full time

    Clinical Trial Manager II (Canada) ICON is hiring for a Clinical Trial Manager II position who will be running the Canadian portion of global trials from start up, maintenance, to close out. Responsible for the Canadian trial deliverable. Direct hire, fully remote position, no travel, with starting pay up to $140K Canadian (No bonus) Must currently, or...

  • Clinical Trial Feasibility Manager

    1 day ago

    Toronto, Canada Novo Nordisk Full time

    Clinical Trial Feasibility Manager **Category**:Clinical Development **Location**:Toronto, Ontario, CA **The Position** - As a Clinical Trial Feasibility Manager, you will: - Partner with strategic clinics to assess the viability of conducting clinical trials. - Lead feasibility locally via digitalisation and interaction with site staff and relevant...

  • Clinical Trial Associate

    3 weeks ago

    Toronto, Canada MolecuLight Full time

    Join to apply for the Clinical Trial Associate role at MolecuLight MolecuLight Inc. is a Medical device company in Toronto, specializing in point-of-care diagnostic imaging, developing a handheld optical imaging platform. MolecuLight’s products are imaging systems with primary applications in bacterial imaging and measurements for wound care. We are...

  • Clinical Trial Associate

    3 weeks ago

    Toronto, Canada MolecuLight Full time

    Join to apply for the Clinical Trial Associate role at MolecuLightMolecuLight Inc. is a Medical device company in Toronto, specializing in point-of-care diagnostic imaging, developing a handheld optical imaging platform. MolecuLight’s products are imaging systems with primary applications in bacterial imaging and measurements for wound care. We are...

  • Clinical Trial Associate

    3 weeks ago

    Toronto, Canada MolecuLight Full time

    Join to apply for the Clinical Trial Associate role at MolecuLightMolecuLight Inc. is a Medical device company in Toronto, specializing in point-of-care diagnostic imaging, developing a handheld optical imaging platform. MolecuLight’s products are imaging systems with primary applications in bacterial imaging and measurements for wound care. We are...