Clinical Operations Line Manager

Planet Pharma; Valley Forge (PA); On-site; USD 138,000 - 165,000; Full time

Job summary

Planet Pharma is seeking a Clinical Operations FSP Line Manager to oversee study management resources, drive process improvements, and implement SOPs across regions. The ideal candidate has 8+ years in Clinical Operations, at least 3 years of line management, deep FSP model experience, and the ability to lead remote teams and coordinate with stakeholders.

You will focus on operational excellence, KPI monitoring, onboarding of resources, and continuous improvement initiatives including dashboards

Qualifications

• 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, regulatory requirements (FDA, EMA), and ICH/GCP guidelines.
• Excellent leadership, communication, and stakeholder management skills, with the ability to influence and resolve conflicts.
• Experience leading remote teams and collaborating across functions and organizational levels.
• Proven project management, planning, analytical, and problem-solving skills.
• Proficiency in Microsoft Office applications and fluent in written and spoken English.

Responsibilities

• Provide direct line management and operational oversight for Clinical Operations FSP resources across regions.
• Conduct regular one-on-one meetings to support day-to-day team management and escalate issues.

Skills

People management

FSP model

Clinical operations

Leadership

Stakeholder management

Remote leadership

Project management

MS Office

English fluency

Tools

MS Office

Job description

Pay range: 100-120/hr

• depending on exp

Brief Description

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 organisational objectives are consistently achieved.

Line Management Responsibilities

• 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
• Oversees 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 Responsibilities

Some activities may include:

• 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

Required Knowledge, Skills, and Abilities

• 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 solution
• Demonstrated ability to lead, develop, and motivate direct reports in a remote environment while collaborating effectively across functions and organisational levels
• Strong project management, planning, analytical, and problem-solving skis
• 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