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kps life · 1 day ago

Head of Site Monitoring and Management

Malvern, PA

Full-time

Hybrid

Director/Executive

10+ years exp

KPS Life is a leader in clinical trial FSP solutions, seeking a Head of Site Monitoring and Management to oversee and enhance their capabilities in site monitoring. The role involves establishing strategic vision, developing processes, and ensuring operational delivery while managing client relationships and leading a high-performing team.

Health CareMedicalWellness

Hiring Manager

Ken DeCarlo

Responsibilities

Establish the strategic vision, structure, and operating model for the Site Management organization within Clinical Services & Delivery

Develop scalable processes, SOPs, and best-practice frameworks for site monitoring, oversight, and relationship management

Serve as a primary point of contact for clients regarding monitoring strategy, site oversight, and operational delivery

Represent the organization in proposal presentations, bid defense meetings, governance forums, and ongoing client updates

Define monitoring strategies (RBM/RBQM, hybrid, traditional) tailored to protocol requirements, site profiles, and risk indicators

Provide expertise in trial design elements that impact monitoring (visit schedules, endpoint structures, safety oversight, data flow, etc.)

Translate client needs into operational solutions, ensuring monitoring approaches are fit-for-purpose and supported by clear resourcing models

Drive continuous improvement in site monitoring through innovation and new technologies

Improve efficiency and cost-effectiveness while maintaining quality

Develop and implement comprehensive inspection-readiness standards, tools, and expectations across the Site Management organization

Ensure all site-facing staff are trained, coached, and routinely assessed on inspection-readiness practices, documentation quality, and escalation discipline

Lead periodic internal reviews/mock inspections to identify gaps early and strengthen overall preparedness for sponsor, regulatory, and QA inspections

Partner with Quality Assurance and Study Leadership to ensure monitoring documentation, TMF contributions, and site communications are always 'inspection ready.'

Qualification

Clinical operationsSite managementLeadership experienceFSP model experienceGlobal clinical trialsICH E6 GCP knowledgeProcess improvementTeam motivationClient communication

Required

At least 10 years of experience in clinical operations or site management

Strong leadership skills to motivate teams to surpass goals

Experience in building and refining processes and tools within an FSP Model

A bachelor's degree in Life Sciences or related field

At least 10-15 years of experience in clinical operations or site management, with a minimum of 5 years in a leadership position managing site monitoring or clinical trial management teams

Proven experience working in or managing services within an FSP model, understanding client-specific requirements, and delivering tailored solutions

Experience managing global clinical trials, with an understanding of the regulatory requirements and challenges in different regions

Proven current working knowledge of ICH E6 GCP and required local regulations, applicable and/or related to the performance of role duties and activities