Country Study Operations Manager II / Sr. Clinical Trial Manager - FSP

Parexel; Quebec; Hybrid; CAD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Study Operations Manager II to lead clinical trials from startup to close. This role demands exceptional leadership and organizational skills, ensuring operational excellence and adherence to project plans. As the driving force behind study execution, you will collaborate with cross-functional teams and manage risks while maintaining high-quality standards. If you have a robust background in clinical trials and a passion for improving patient outcomes, this opportunity offers a chance to make a significant impact in a dynamic environment.

Qualifications

• 7+ years of operational clinical trial experience required.
• Master's degree preferred for advanced roles.

Responsibilities

• Lead local study team and oversee study startup processes.
• Manage and maintain accurate country-level plans.

Skills

Leadership

Strategic Planning

Organizational Skills

Clinical Trial Management

Risk Management

Education

Bachelor’s of Science

Bachelor’s of Arts

Master’s of Science

Master’s of Business Administration

Job description

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

The Study Operations Manager II (SOM II) is responsible for study and regional or specific country level activities from study startup through conduct and study close on one or more studies. The role involves providing leadership, strategic planning, and organizational skills to ensure the operational delivery of tasks.

Responsibilities:

1. Serve as the leader of the local study team on one or more studies.
2. Provide backup to or assume the responsibilities of the GSM as needed.
3. Oversee the preferred Contract Research Organization and/or Country Trial Manager / Site Care Partner for assigned studies at the country level, ensuring adherence to the overall project plan, and manage and maintain accurate country-level plans (e.g., timelines, budgets, risks, and quality plans).
4. Manage the study startup process in assigned countries and/or oversee the CRO responsible for these activities as applicable.
5. Liaise with SCP, Lead SCP, Site Activation Partners, and regulatory colleagues in-country to agree on submission strategies to Health Authorities (HAs) and Ethics Committees (ECs).
6. Provide country-level input on startup and recruitment milestones during planning.
7. Collaborate with accountable roles to identify and manage deviations and risks in study startup and execution, implementing mitigation strategies as required.
8. Be accountable for resolving site activation escalations to study teams, including offering mitigation options.
9. Be fully responsible and accountable for, as designated by the GSM: regional, country, and study-level implementation of startup and site activation plans; recruitment strategies; development of study-level plans; communication with the local team, internal stakeholders, and CRO; vendor management and oversight; and ensuring follow-up on quality events, protocol deviations, data issues, metrics review, site issues, risks, and audit responses.

Requirements:

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