Global Clinical Study Lead — Hybrid

KPS Life; Cambridge (MA); Hybrid; USD 140,000 - 190,000; Full time

Job summary

KPS Life is seeking a Clinical Study Lead (CSL) to oversee global trial execution from design through closeout, leading cross-functional teams and managing CROs, budgets, and timelines. The role requires 5+ years in study leadership with strong ICH-GCP knowledge and vendor management.

Position is hybrid with offices in Cambridge, MA; Armonk, NY; or Warren, NJ. Bachelor's degree required; advanced degree considered. Strong data-driven and communication skills are essential.

Qualifications

• Bachelor's degree or equivalent; advanced degree may substitute for experience.
• Experience in global clinical trial operations and protocol development.
• Demonstrated cross-functional leadership, project management, and organization.
• Vendor management and budget management experience.
• Strong ICH-GCP knowledge and regulatory understanding.
• Technical proficiency with CTMS, EDC, IWRS/IVRS, and Microsoft tools.
• Strong communication, presentation, and interpersonal skills.
• Data-driven planning, problem solving, and decision making.
• Ability to build productive teams and manage competing priorities.

Responsibilities

• Lead cross-functional study teams and serve as a key contact for study leadership.
• Provide operational input into protocol development and key study documents.
• Lead feasibility assessments, country selection, site evaluation, and investigator meetings.
• Oversee timelines, milestones, site activation, monitoring, recruitment and retention.
• Manage budgets, vendor contracts, scope changes, and forecasting.
• Oversee CTMS and TMF systems and ensure timely data entry and queries.
• Lead study-level risk assessments and mitigation strategies.
• Monitor data quality, deviations, and site compliance.
• Support audits, CAPAs, and regulatory readiness.
• Lead vendor engagement and CRO performance oversight.
• Escalate issues and drive timely resolution affecting quality/timeline.
• Oversee closeout activities like database lock and study report review.

Skills

Cross-functional leadership

Project management

Vendor management

ICH-GCP knowledge

CTMS

EDC

IWRS/IVRS

Microsoft Project

Communication skills

Data-driven planning

Education

Bachelor's degree or equivalent

Advanced degree considered in lieu of experience

Tools

CTMS

EDC

IWRS/IVRS

Microsoft Teams

MS Office/Project

Job description

KPS Life is seeking a Clinical Study Lead (CSL) to oversee global trial execution from design through closeout, leading cross-functional teams and managing CROs, budgets, and timelines. The role requires 5+ years in study leadership with strong ICH-GCP knowledge and vendor management.

Position is hybrid with offices in Cambridge, MA; Armonk, NY; or Warren, NJ. Bachelor's degree required; advanced degree considered. Strong data-driven and communication skills are essential.