Country Study Ops Manager — Clinical Trials Leader

Socket.dev; Canada; Hybrid; CAD 65,000 - 95,000; Full time

Job summary

Parexel is seeking a Study Operations Manager I to oversee study startups through closeout across one or more studies, with leadership for regional activities. The role emphasizes strategic planning, operational delivery, and cross-functional collaboration to support global trials.

The SOM I will liaise with GSMs, pCROs, CTMs/SCPs, and regulatory colleagues to ensure timely startup and execution, while maintaining TMF completeness and adherence to ICH-GCP standards.

Qualifications

• Fluency in written and spoken English required.
• 3-5 years clinical trial study management experience.
• Comprehensive knowledge of own discipline with cross-disciplinary awareness.
• Experience coordinating tasks within a study management team.
• Good knowledge of Good Clinical Practice and regulatory operations.
• Clinical research and/or startup project management experience.
• Experience managing country-level operational activities and vendors.
• Knowledge of clinical trial methodology.
• Experience in a matrix management environment.
• Relevant operational clinical trial experience.

Responsibilities

• Lead specific parts of the study and drive country-level deliverables.
• Oversee local study teams and coordinate with pCRO/CTM/SCP.
• Manage startup activities and landing submissions with health authorities.
• Collaborate to identify risks and implement mitigation strategies.
• Ensure Trial Master File completeness and regulatory compliance.

Skills

Study management

Reporting tools

Risk management

Communication

Independent work

Analytical thinking

Matrix environment

Education

Bachelor's degree in a relevant field

Job description

Parexel is seeking a Study Operations Manager I to oversee study startups through closeout across one or more studies, with leadership for regional activities. The role emphasizes strategic planning, operational delivery, and cross-functional collaboration to support global trials.

The SOM I will liaise with GSMs, pCROs, CTMs/SCPs, and regulatory colleagues to ensure timely startup and execution, while maintaining TMF completeness and adherence to ICH-GCP standards.