Hybrid Global Clinical Study Lead | Cross-Functional Leader

KPS Life; Warren (MA); Hybrid; USD 140,000 - 170,000; Full time

Job summary

KPS Life is seeking a Clinical Study Lead to manage global clinical trials from design through closeout. This role leads cross‑functional teams, oversees timelines, budgets, quality, and regulatory compliance, and supervises CRO activities.

The CSL role requires 5+ years in global trial operations, strong leadership, and proficiency with CTMS/EDC/IWRS/IVRS. Travel up to 25% may be required; hybrid work in Armonk, NY or Warren, NJ or Cambridge MA.

Qualifications

• Bachelor's degree or equivalent; advanced degree may substitute.
• Global clinical trial operations experience with protocol development.
• Strong cross-functional leadership and project management skills.
• Vendor management and budget experience.
• ICH‑GCP and regulatory guidelines knowledge.
• Experience with CTMS, EDC, IWRS/IVRS, and Microsoft tools.

Responsibilities

• Lead cross-functional study teams and act as main study leadership point.
• Provide input into protocol development and key study documents.
• Oversee feasibility assessments, country selection, site evaluation, and investigator meetings.
• Oversee study timelines, milestones, site activation, recruitment, and retention strategies.
• Manage budgets, vendor contracts, scope changes, and drug/clinical supplies forecasting.
• Ensure CTMS/TMF data entry and quality; drive issue resolution.
• Lead risk assessments and mitigation; monitor data quality and protocol compliance.
• Oversee CRO/vendor engagement; escalate risks affecting quality, timelines, or budgets.
• Oversee closeout activities including database lock, TMF completion, and CSRs.

Skills

Cross-functional leadership

Project management

Budget management

ICH-GCP knowledge

CTMS proficiency

EDC/IWRS/IVRS

Microsoft Office/Teams/Project

Strong communication

Data-driven planning

Travel readiness

Education

Bachelor's degree or equivalent

Advanced degree preferred

Tools

CTMS

EDC

IWRS/IVRS

Job description

KPS Life is seeking a Clinical Study Lead to manage global clinical trials from design through closeout. This role leads cross‑functional teams, oversees timelines, budgets, quality, and regulatory compliance, and supervises CRO activities.

The CSL role requires 5+ years in global trial operations, strong leadership, and proficiency with CTMS/EDC/IWRS/IVRS. Travel up to 25% may be required; hybrid work in Armonk, NY or Warren, NJ or Cambridge MA.