Clinical Trial Manager

6 months 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

  • Clinical Trials Coordinator Lead

    5 days ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services Inc, a leading contract research organization (CRO), is seeking an experienced Clinical Trials Coordinator Lead to join our team in Toronto/Markham, Ontario, Canada.Job Summary:As a Clinical Trials Coordinator Lead, you will be responsible for providing exceptional support to clients and internal teams in the delivery of...

  • Statistical Director for Clinical Trials

    5 days ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Job SummaryWe are seeking a skilled Statistical Director to join our team at Everest Clinical Research Services Inc in Bridgewater, New Jersey. As a key member of our Biostatistics department, you will be responsible for managing clinical trial programs and projects from start to finish.

  • Senior Clinical Trial IWRS Operations Manager

    1 month ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Job Title: Senior Clinical Trial IWRS MonitorEverest Clinical Research Services Inc is seeking a highly skilled and experienced Senior Clinical Trial IWRS Monitor to join our team. As a key member of our Clinical Trials Technology (CTT) unit, you will be responsible for providing exceptional customer service and support to our clients and internal...

  • Clinical Trial Manager

    2 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Senior Clinical Trial LeaderAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials.We are seeking a Senior Clinical Trial Leader to join our team. As a Senior Clinical Trial Leader, you will be responsible for providing leadership, management, and oversight to Clinical Research...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionWe are seeking a highly skilled Clinical Trials Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other functional groups in their day-to-day clinical trial activities.Key...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Senior Clinical Trial LeaderWe are seeking a highly skilled and experienced Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and oversight to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionWe are seeking a highly skilled and experienced Clinical Trials Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial activities.Key...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionJob Title: Clinical Trials ManagerJob Summary:We are seeking a highly skilled Clinical Trials Manager to join our team at Allucent. As a Clinical Trials Manager, you will be responsible for providing leadership and management to our clinical research associates and other functional groups in their day-to-day clinical trial activities.Key...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are seeking a Senior Clinical Trial Leader to join our team. As a Senior Clinical Trial Leader, you will be responsible for providing...

  • Clinical Trials Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionWe are seeking a highly skilled Clinical Trials Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other functional groups in their day-to-day clinical trial activities.Key...

  • Clinical Trial Manager

    5 months 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, Clinical Operations

    5 months ago

    Toronto, Canada Moderna Full time

    **The Role**: The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial(s) ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs. The position reports to the Director, Clinical Operations and is accountable to the Clinical...

  • Clinical Trial Manager, Clinical Operations

    5 months ago

    Toronto, Canada Moderna Full time

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

  • Clinical Trials IWRS Data Management Specialist

    5 days ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Everest Clinical Research Services IncWe are a full-service contract research organization (CRO) dedicated to providing high-quality clinical research services to the pharmaceutical, biotechnology, and medical device industries worldwide.Job Description:As a Clinical Trials IWRS Data Management Specialist, you will be responsible for ensuring the accuracy...

  • Clinical Trial Operations Manager

    4 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Job DescriptionWe are seeking a highly skilled and experienced Clinical Trial Operations Manager to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership and management to our Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial...

  • Clinical Trials Leader

    2 weeks ago

    Toronto, Ontario, Canada Allucent Full time

    Senior Clinical Trial LeaderWe are seeking a skilled Senior Clinical Trial Leader to join our team at Allucent. As a key member of our clinical operations team, you will be responsible for providing leadership, management, and oversight to Clinical Research Associates (CRAs) and other clinical functional groups.The ideal candidate will possess a strong...

  • Project Manager

    1 month ago

    Toronto, Ontario, Canada Innovaderm Research Full time

    Job DescriptionJob Title: Project Manager - Clinical TrialsJob Summary:We are seeking an experienced Project Manager to lead our clinical trials team. The successful candidate will have a strong background in project management, excellent communication skills, and the ability to work effectively in a fast-paced environment.Key Responsibilities:Lead the...

  • Clinical Research Project Manager

    5 months ago

    Toronto, Canada SickKids Full time

    **About SickKids**: Dedicated exclusively to children and their families, The Hospital for Sick Children (SickKids) is one of the largest and most respected paediatric healthcare centres in the world. As innovators in child health, we lead and partner to improve the health of children through the integration of healthcare, leading-edge research and...

  • Clinical Trial Educator

    5 months ago

    Toronto, Canada Headlands Research Full time

    Overview: Toronto Memory Program, a Headlands Research site, is Canada’s largest and most experienced site for drug treatment trials in Alzheimer’s disease and related conditions. Founded in 1996, we have made significant contributions to over 100 drug treatment studies in Alzheimer’s disease. Our Medical Director, Dr. Sharon Cohen, a Canadian-trained...

  • Clinical Research Proposal Manager

    4 weeks ago

    Toronto, Ontario, Canada Everest Clinical Research Services Inc Full time

    Job Title: Clinical Research Proposal ManagerJob Summary:We are seeking a highly skilled Clinical Research Proposal Manager to join our team at Everest Clinical Research Services Inc. As a key member of our proposals and contracts team, you will be responsible for developing and managing proposals for clinical trials, ensuring that they meet the highest...