Clinical Study Operations Lead

1 month ago


Toronto, Ontario, Canada Parexel Full time

Achieving excellence through aligned values.

The Clinical Study Operations Lead (CSOL) is accountable for overseeing study and regional or specific country level activities from the initiation of the study through its execution and closure across multiple studies. This role demands strong leadership, strategic foresight, and organizational capabilities to ensure the effective operational execution of tasks. Collaborates with Global Study Managers (GSMs), fellow Study Operations Managers, and the broader study management team to facilitate the study by spearheading specific project components, managing particular countries, executing moderately complex tasks, and crafting solutions to challenges that arise to meet deliverables. Acts as the leader of the local study team, which includes core members, ad hoc participants, and other essential stakeholders as necessary for one or more studies. Supervises the preferred Contract Research Organization (CRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for designated studies at the country level, ensuring alignment with the overall project strategy, while managing and maintaining precise country-level plans (e.g., timelines, budget, risk, and quality plans). May oversee the study initiation process in assigned countries [in instances where the Start Up Project Manager (SUPM) is not designated] and/or supervise the CRO responsible for these activities as applicable. Provides country-specific insights on initiation and recruitment milestones. Works collaboratively with accountable roles to identify and address deviations and risks in study initiation and execution, implementing necessary mitigation strategies. Responsible for resolving site activation escalations to study teams, including proposing options for mitigation.

Required Qualifications:

Bachelor’s degree in Science or Arts with a minimum of 7 years of pertinent operational clinical trial experience. Master’s degree in Science or Business Administration with at least 6 years of relevant operational clinical trial experience. A scientific or technical degree is preferred.

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