Senior Clinical Study Lead - Global Trials (Hybrid)

KPS Life; Warren (MA); Hybrid; USD 130,000 - 180,000; Full time

Job summary

KPS Life is seeking a Sr. Clinical Study Lead to lead global trials from planning through closeout, overseeing study execution, timelines, budgets, CROs, and quality. This role requires strong study leadership, vendor management, and global trial experience.

This hybrid position supports three days per week in sponsor offices (Armonk, NY; Warren, NJ; Cambridge, MA) with significant cross-functional collaboration and travel up to 25% to ensure program success.

Qualifications

• Bachelor's degree or equivalent; 8+ years in global clinical trial operations.
• Experience leading cross-functional study teams and CRO oversight.
• Strong vendor and budget management; ICH-GCP knowledge.
• Technical proficiency with CTMS, EDC, IWRS/IVRS; MS Teams and Office.
• Excellent communication, planning, and problem-solving skills.

Responsibilities

• Lead cross-functional study teams and act as key point of contact for study leadership.
• Provide operational input into protocol development and key study documents.
• Oversee feasibility assessments, country selection, site evaluation, and investigator meetings.
• Oversee study timelines, milestones, site activation, monitoring, recruitment and retention strategies.
• Manage study budgets, vendor contracts, scope changes, and drug supply forecasting.
• Oversee CTMS, TMF, data entry and query resolution.
• Lead study-level risk assessments and mitigation strategies.
• Monitor data quality, protocol deviations, and site compliance.
• Support audits and inspections readiness, CAPAs, and regulatory compliance.
• Lead vendor engagement and oversee CRO performance; drive issue resolution.
• Oversee closeout activities including database lock, TMF completion, drug accountability, and study report review.

Skills

Cross-functional leadership

Project management

Vendor management

Budget management

ICH-GCP

Communication

Data-driven planning

Problem-solving

Team building

Travel readiness

Education

Bachelor's degree

Tools

CTMS

EDC

IWRS/IVRS

Microsoft Teams

Microsoft Office

Project

Job description

KPS Life is seeking a Sr. Clinical Study Lead to lead global trials from planning through closeout, overseeing study execution, timelines, budgets, CROs, and quality. This role requires strong study leadership, vendor management, and global trial experience.

This hybrid position supports three days per week in sponsor offices (Armonk, NY; Warren, NJ; Cambridge, MA) with significant cross-functional collaboration and travel up to 25% to ensure program success.