Local Jobs in Shelburne, ON

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Job Summary :

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 the pipeline through accurate planning and efficient execution of trials that bring speed & value to participating patients and sites.

Key Accountabilities :

Trial Preparation

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

• Ensure the trial is conducted in compliance with GCP-ICH, 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 site level 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 on patient value
• Frontloading of activities where possible at the R / OPU level to facilitate efficiencies as well as to ensure and leverage speed.
• Oversees outsourcing of vendor services in the R / OPU in accordance to operating models and governance.
• Ensure timely responses to questions from Regulatory Authority / Ethics Committee and other external stakeholders.

Trial Conduct

Trial Closeout and Reporting

General accountabilities

Interfaces :

Functional lead and / or project manager of local / regional trial team members and colleagues including but not limited to :

Requirements :

Minimum Education Requirements :