Clinical Operations Manager-FSP

Role overview

Study management

• Manage country deliverables, timelines, quality, compliance, and results for assigned protocols.
• Coordinate with clinical, finance, legal, regulatory, pharmacovigilance, regional, and headquarters teams.
• Oversee local vendors, clinical supplies, import and export processes, filing, archiving, retention, and insurance processes.
• Enter and update country information in clinical and finance systems.

Finance and regulatory management

• Own country and site budgets and oversee Clinical Trial Research Agreement development, negotiation, and completion.
• Track clinical research payments and reconciliation at study close-out.
• Oversee financial controls, screening requirements, financial systems, and forecasting as applicable.
• Execute country submissions and approvals and interact with ethics committees and regulatory authorities.
• Develop local-language informed consents and translations.

Team development and compliance

• Contribute to process improvement, knowledge sharing, training, mentoring, and business initiatives.
• Complete required training, timesheets, expense reports, and other Parexel process obligations.
• Maintain working knowledge of Parexel processes, ICH-GCP, and applicable requirements.

Required capabilities

• Strong knowledge of budget and contract negotiations, local regulatory requirements, and submission and approval processes.
• Ability to make independent decisions, resolve issues locally, and develop risk mitigation plans.
• Strong coordination, organization, communication, leadership, negotiation, influencing, training, and mentoring skills.
• Ability to manage multiple protocols and deliverables in a remote virtual environment.
• English and applicable local-language communication skills are required, with minimal travel.

Workplace

• The description identifies the role as hybrid in Canada.

About Parexel