Senior Manager, Local Study Operations

This is a fully remote position, open to applicants in Canada.

📋 Description

• Lead the development of skills for Local Study Operations Managers (LSOMs) and ensure effective trial execution within the country.

• Supervise the delivery of the country's study portfolio, managing scope, timelines, and budgets through LSOM leadership.

• Cultivate and maintain an optimal clinical research environment that aligns with global R&D objectives.

• Promote alignment and continuous enhancement in LSOM execution through the adoption of best practices, digital innovation, and knowledge sharing.

• Ensure the successful execution of the study portfolio assigned to LSOMs.

• Oversee LSOM responsibilities from feasibility assessments to study close-out.

• Monitor portfolio progress while providing oversight on risk and quality.

• Assist in the escalation and resolution of issues.

• Manage the performance of LSOMs and vendors, serving as the primary escalation point for local study challenges.

• Mentor, train, and support the professional growth of LSOMs.

• Build and sustain a high-performing team.

• Facilitate collaboration between study strategy and local study teams.

• Encourage cross-functional cooperation among country teams.

• Support decisions related to study placements based on country capabilities and potential for growth.

• Assess risks, quality trends, and resource needs; implement strategies for mitigation.

• Lead initiatives for operational efficiency and best practices.

• Manage resource allocation and workload distribution among LSOMs, including FSP and FTE personnel.

• Ensure compliance with regulatory and quality standards.

• Assist the country head in stakeholder engagement, trial deliverables, and escalations.

⛳️ Requirements

• Doctorate degree with 2 years of clinical execution experience, or Master's degree with 6 years, or Bachelor's degree with 8 years, or Associate's degree with 10 years, or high school diploma/GED with 12 years.

• At least 2 years of direct people management or leadership experience leading teams, projects, programs, or resource allocation.

• Advanced proficiency in English.

• Preferred: 7 years of experience in life sciences or a medically related field.

• Preferred: 4 years of clinical research experience in biopharmaceuticals, particularly in clinical trials within a biotech, pharmaceutical, or CRO company.

• Experience managing multiple teams or direct reports across various clinical functions or trials.

• Experience overseeing clinical research vendors, including CROs, central labs, and imaging vendors.

• Experience managing clinical operations in the relevant geography/region.

• Strong knowledge of local regulatory requirements for global clinical trials.

🏝️ Benefits

• Health and welfare plans for employees and eligible dependents.

• Financial plans that provide opportunities for saving towards retirement or other goals.

• Support for work/life balance.

• Opportunities for career development.

• Reasonable accommodations for individuals with disabilities.

• An inclusive and collaborative culture.