Demo

Head of Site Monitoring and Management

kps life
Malvern, PA Full Time
POSTED ON 11/23/2025
AVAILABLE BEFORE 12/20/2025
We're Hiring a Head of Site Monitoring & Management

Location: Malvern, PA | Hybrid in office

  • Do you have at least 10 years of experience in clinical operations or site management?
  • Are you a strong leader who can motivate teams to surpass goals?
  • Have you built and refined processes and tools within an FSP Model?

…If so, this may be the perfect opportunity for you!!

Join a growing leader in clinical trial FSP solutions!

KPS Life is looking for a Head of Site Monitoring and Management. This role will oversee and enhance KPS Life capabilities in site monitoring, standardize processes and systems and manage customer delivery. The role is at the Director level and will leverage deep clinical expertise and consult with customers to create solutions designed to meet the site-facing needs of the Sponsor.

As a stand-alone Functional Service Provider (FSP) focused exclusively on clinical research, we pride ourselves on white-glove service, flexibility, and Sponsor-first thinking. If you're ready to shape proposal strategy, drive pricing innovation, and lead a high-performing team—we’d love to hear from you.

What You’ll Do

  • 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.”

What You Bring

  • 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

Why KPS Life?

We're purpose-built to deliver excellence in clinical trial sourcing through our focused FSP model. Join a growth-oriented company that values agility, precision, and partnership—with clients and with each other.

#kpslife

Salary.com Estimation for Head of Site Monitoring and Management in Malvern, PA
$174,154 to $219,398
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