CTM​/Clinical Trial Manager

Job Title:

CTM/Clinical Trial Manager

Location:

Toronto, Ontario

Type:
Contract
Compensation: $55 - $60 hourly
Contractor Work Model:
Hybrid

Clinical Trial Manager

Location:

Hybrid, Metro Toronto (Burlington) - 50% per month onsite

September Start
12 months contract+ (through 2026)

Pay: $55 to $60 per hour

Job Description:

The Clinical Trial Manager (CTM) is accountable for the operational and scientific
oversight, the set-up, execution and delivery of their assigned clinical trials at the
regional/local level. CTMs contribute to delivery of BI’s pipeline through accurate
planning and efficient execution of trials that bring speed & value to participating
patients and sites.

The CTM provides leadership and direction to the R/OPU trial team for their
responsible R/OPU and is accountable for the overall success and delivery of their assigned clinical trial/s according to defined milestones and key performance indicators (e.g. Medicine Excellence KPIs
-Med Ex). They are responsible for steering and directing clinical trial activities,including patient and site engagement activities, direct communication and interaction with multiple internal and external stakeholders (e.g. investigative sites) and trial team members at a regional/local andglobal level.

The CTM is responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation. The CTM serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader (“CTL”) onall study-related issues. As leader of the R/OPU Trial Team, the CTM communicates trial status to stakeholders, escalating issues as appropriate.

Trial Preparation Accountabilities:
Accountable for the trial activities for responsible R/OPU, including but not limited to:

• Ensure the trial is conducted in compliance with GCPICH,local/global regulations, applicable SOPs and according to the trial protocol by overseeing CRO and internal team activities.
• Creation, management and review of the R/OPU trial budget to ensure appropriate level of financial oversight and planning accuracy. Timely budget updates based on trial changes.
• Appropriate trial-specific training of R/OPU internal and external partners is performed in line with Trial Training Plan.
• Accurate planning and co-ordination of operational feasibility of trial timelines for their R/OPU; and oversight of trial preparation to ensure trial team members are aligned and on track.
• Verifies and provides input into the country and sitelevel feasibility and OPU commitment (site and patient commitment). Finalize and validate site selection using available data sources and local insights/expertise, in collaboration with other functions (i.e. Medical Affairs, vendors if applicable).
• Development and implementation of country level engagement plans, recruitment planning and risk mitigation. Co-ordinates development of country level patient facing documents in close collaboration with relevant internal and external stakeholders. Reports patient and site level feedback as strategic insight to contribute to improving trial design with a focus onpatient value
• Front loading of activities where possible at the R/OPU level to facilitate efficiencies as well as toensure and leverage speed.
• Oversees outsourcing of vendor services in the R/OPUin accordance to operating models and governance.
• Ensure timely responses to questions from Regulatory Authority/Ethics Committee and other external stakeholders.

• Adheres to trial planning and commitment as per Med Extarget KPIs. Core documents filed in Trial Master Fileas per planned timelines.
  
  Ensures timely update oftrial management systems.
• Regular communication maintained with local trialteam, internal and external partners.
• Implementation and incorporation of patientcentric initiatives to optimize trial delivery andbring value to patients.
  
  Engagement plans in place,including recruitment and contingency planning.

• Maintains oversight during clinical trial conductincluding adherence to GCP and all global and local regulatory requirements; compliance with SOPs and continuous risk monitoring/mitigation. In collaboration with other functions, ensures budget oversight, including support of regular clinical quality monitoring, and safety reporting.
• Monitor progress of patient recruitment endpoints and proactively update and action contingencies throughouttrial conduct.
• Support CTL during investigator meetings
• Establish and maintain relationships with…