Director, Local Study Operations Manager

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

📋 Description

• Deliver strategic and operational direction for the country's LSOM organization.

• Supervise the quality, timeliness, cost-effectiveness, and compliant execution of the national clinical study portfolio.

• Convert global clinical development strategy into local operational priorities.

• Guide portfolio delivery, resource and capacity planning, financial management, quality and risk assessment, vendor performance, and inspection readiness from feasibility to study closure.

• Impact study placement and portfolio decisions.

• Lead the resolution of major operational challenges.

• Cultivate organizational capability and succession plans.

• Represent LSOM operations in national, regional, and global governance meetings.

• Oversee the delivery of the national study portfolio through the LSOM management organization.

• Establish oversight of delivery, quality, risk, timelines, and performance at the portfolio level.

• Manage the performance of LSOM and vendors and act as the primary escalation point for local study issues.

• Enhance leadership skills through coaching, development, and succession planning.

• Collaborate with CRA, CSPO, Quality, FSP, Regional Head, Country Head, and other cross-functional stakeholders.

• Coordinate country functional teams to ensure successful portfolio delivery.

• Ensure inspection readiness and offer hands-on support during inspections, including responsibility for storyboards.

• Champion continuous operational improvement, digital innovation, and the adoption of best practices.

• Direct resource strategy, capacity planning, and workload distribution across FSP and FTE LSOM teams.

• Ensure adherence to regulatory, GCP, ICH, quality, and organizational standards.

• Lead, mentor, and develop LSOM Senior Managers, including performance management and talent growth.

• Promote a high-performing, inclusive, accountable, and patient-centric culture across geographically diverse teams.

• Drive organizational changes and the adoption of new operating models and technologies.

⛳️ Requirements

• Doctorate degree with 4 years of clinical research experience OR Master’s degree with 7 years of clinical research experience OR Bachelor’s degree with 9 years of clinical research experience.

• 4 years of direct managerial and/or leadership experience or equivalent.

• Extensive knowledge of ICH GCP, ICH E6(R3), ICH E8(R1), and global regulatory requirements for risk-based monitoring and clinical trial oversight.

• Demonstrated ability to influence senior stakeholders and lead complex cross-functional initiatives within a global matrix organization.

• Strong project management expertise.

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

• Experience working with or overseeing clinical research vendors (CROs, central labs, imaging vendors, etc.).

• Experience managing clinical operations in relevant geographic regions.

• Solid understanding of local regulatory requirements regarding global clinical trials.

🏝️ Benefits

• Comprehensive employee benefits package.

• Retirement and savings plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Financial plans with opportunities to save for retirement or other goals.

• Career development opportunities.

• Support for work/life balance.

• Reasonable accommodations for applicants and employees with disabilities.