Parexel

Study Operations Manager II/Senior Clinical Operations Leader - FSP

Canada · Work style not stated

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About the role

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EmployerParexel
LocationCanada
Work styleWork style not stated
Employer posted17 Aug 2026

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Study Operations Manager has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks.

Serves as leader of the local study team on one or more studies
Provides back up to or assumes the responsibilities of the GSM as needed
Oversees the preferred Contract Research Organization and/or Country Trial Manager/Site Care Partner for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans)
May manage the study start up process in countries assigned and/or oversee the CRO responsible for these activities as applicable
Liaises with SCP, Lead SCP, Site Activation Partners and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethics Committees (ECs)
Provides country level input on startup and recruitment milestones during planning
Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required.
Accountable for resolution of site activation escalations to study teams including offering options for mitigation
Fully responsible and accountable for, as designated by the GSM:

Show full description

Regional, country, and study level implementation of startup and site activation plans
Regional, country and study level recruitment strategy
Development of study level plans
Communication with the local team and internal stakeholders and CRO as applicable to ensure efficient and timely study delivery of the agreed plans
Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables
Assurance of the follow up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc.

Requirements:

Bachelor’s of Science or Bachelor’s of Arts degree with a minimum 5 years of relevant operational clinical trial experience required
Master’s of Science or Master’s of Business Administration degree with a minimum 3 years of relevant operational clinical trial experience required
A scientific or technical degree is preferred

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