Clinical Operations Line Manager

Pay range: $100–120/hr depending on experience.

About the role

The Clinical Operations FSP Line Manager supports the successful execution of clinical study management activities through FSP Resource oversight, process optimization, and operational implementation initiatives. This role has a strong focus on the line management and day-to-day oversight of FSP resources within the Clinical Operations Study Management team. It may also include driving continuous improvement efforts through the development, maintenance, and implementation of processes, tools, dashboards, standard operating procedures (SOPs), and related operational resources. The ideal candidate combines strong people management skills with operational excellence, ensuring that teams are aligned, processes are efficient, and organizational objectives are consistently achieved.

Responsibilities

Line Management

• Provide direct line management and operational oversight for Clinical Operations FSP resources in multiple countries and regions.
• Conduct regular one-on-one meetings to support day-to-day team management, address and resolve operational issues, and serve as an escalation pathway within Clinical Operations Study Management.
• Monitor and support FSP Resource day-to-day workload, resource allocation, and study performance against established objectives and key performance indicators (KPIs).
• Facilitate onboarding, training, and integration of new FSP Resources into the Clinical Operations Study Management team.
• Collaborate with supplier partners and internal stakeholders to ensure successful delivery of work and address performance concerns.
• Oversee Pharmaceuticals training compliance of FSP Resources related to SOPs, systems, and processes.
• Foster a positive, collaborative, and high-performing team environment.

Process Improvement and Implementation

• Support the development, review, and continuous improvement of Clinical Operations Study Management processes as a clinical operations subject matter expert (SME).
• Collaborate with Clinical Operations leadership, study teams, quality representatives, and supplier partners to implement operational initiatives.
• Partner with cross-functional stakeholders to identify process gaps, operational risks, and opportunities for increased efficiency.
• Lead or contribute to the implementation of new processes, standards, and best practices across the organization.
• Communicate process updates, procedural changes, and implementation plans to impacted stakeholders.
• Provide regular updates on implementation progress, risks, and opportunities.
• Participate in functional meetings and training initiatives, as applicable.
• Support change management activities to ensure successful adoption of process improvements, including championing new AI platforms and future ways of working.

Requirements

• Minimum 8 years of Clinical Operations experience, including at least 3 years of people/line management experience.
• Strong understanding of the FSP model and its integration within a sponsor environment.
• Comprehensive knowledge of clinical trial operations, drug development, ICH/GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA).
• Excellent leadership, communication, and stakeholder management skills, with the ability to influence, negotiate, resolve conflicts, and effectively communicate risks and solutions.
• Demonstrated ability to lead, develop, and motivate direct reports in a remote environment while collaborating effectively across functions and organizational levels.
• Strong project management, planning, analytical, and problem-solving skills.
• Exercises sound judgment and independent decision-making, demonstrating innovation, adaptability, and attention to detail.
• Proficient in Microsoft Office applications (Excel, Word, PowerPoint) and fluent in written and spoken English.