Clinical Trial Operations Lead

Kps-Life; Malvern (Chester County); On-site; USD 120,000 - 160,000; Full time

Job summary

Kps-Life is seeking a Clinical Trial Manager to lead cross-functional study teams ensuring timely, compliant delivery of clinical research deliverables. You will oversee startup, conduct, close-out, and vendor oversight while ensuring adherence to GCP, FDA requirements, and SOPs.

The role demands strong leadership, stakeholder communication, and proven ability to manage CROs, develop study processes, and maintain project timelines across multiple studies.

Qualifications

• BS degree in biology, allied health, nursing or related life science preferred.
• 5+ years related experience in clinical study execution.
• Experience leading a study or significant participation on a study team through major milestones.
• Experience managing CROs and other external providers.
• Strong ability to develop study processes and oversee study design and execution.
• Proven skills in cultivating relationships with healthcare professionals and cross-functional teams.

Responsibilities

• Lead cross-functional study teams to deliver clinical research deliverables on time, within budget and with quality.
• Oversee study operational plan startup, conduct, close-out and vendor oversight with regulatory and SOP adherence.
• Develop and apply standardized processes, metrics and tools to improve study operations and performance.

Skills

Clinical trial management

GCP knowledge

Regulatory compliance

Stakeholder communication

Vendor management

Timeline development

Cross-functional collaboration

Study leadership

Education

BS in biology/allied health/nursing/life science

Tools

CTMS

eDC

eTMF

Job description

Kps-Life is seeking a Clinical Trial Manager to lead cross-functional study teams ensuring timely, compliant delivery of clinical research deliverables. You will oversee startup, conduct, close-out, and vendor oversight while ensuring adherence to GCP, FDA requirements, and SOPs.

The role demands strong leadership, stakeholder communication, and proven ability to manage CROs, develop study processes, and maintain project timelines across multiple studies.