Clinical Study Lead (CSL)

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

Clinical Study Lead (CSL) - (Warren, NJ, Armonk NY or Cambridge, MA)

Warren, NJ, Armonk NY or Cambridge, MA

Opportunity Details

On Assignment Clinical Study Lead (CSL) - (Warren, NJ, Armonk NY or Cambridge, MA)

KPS Life is hiring a Clinical Study Lead to be fully dedicated to our sponsor partner and work 3 days a week in one of their offices located in Armonk, NY, Warren, NJ or Cambridge MA.

KPS Life is hiring a Clinical Study Lead to be fully dedicated to our sponsor partner and work 3 days a week in one of their offices located in Armonk, NY, Warren, NJ or Cambridge MA.

This role offers the opportunity to lead complex global clinical trials from planning through closeout, overseeing study execution, cross-functional teams, CROs, budgets, timelines, and quality. We’re looking for an experienced clinical operations professional with at least 5+ year experience in study leadership, vendor management, and global trial experience.

Clinical Study Lead (CSL)

Global Clinical Operations | Hybrid | Armonk, NY • Warren, NJ • Cambridge, MA

Position Overview

The Clinical Study Lead (CSL) supports the global execution of large and/or complex clinical trials from study design through closeout. This role leads cross-functional study teams and oversees study timelines, budgets, quality, and compliance with SOPs and ICH-GCP requirements. Responsibilities include both direct study leadership and oversight of CRO-managed studies.

Key Responsibilities

Study Leadership & Strategy

Lead cross-functional study teams and serve as a key point of contact for study leadership and oversight.

Provide operational input into protocol development and key study documents.

Lead feasibility assessments, country selection, site evaluation, and investigator meetings.

Study Execution & Delivery

Oversee study timelines, milestones, site activation, monitoring progress, recruitment, and retention strategies.

Manage study budgets, vendor contracts, scope changes, and clinical supplies forecasting.

Oversee study systems, including CTMS and TMF, and ensure timely data entry and query resolution.

Lead study-level risk assessments and implement mitigation strategies.

Monitor data quality, protocol deviations, site compliance, and study performance metrics.

Support audit and inspection readiness, CAPAs, and compliance with ICH-GCP and regulatory requirements.

Lead vendor engagement and oversee CRO and third-party vendor performance.

Escalate study issues and drive resolution of risks affecting quality, timelines, or budgets.

Oversee closeout activities, including database lock, TMF completion, drug accountability, and clinical study report review.

Support Clinical Study Management staff and contribute to lessons learned.

Requirements & Qualifications

Bachelor's degree or equivalent and at least 5+ years of relevant industry experience; an advanced degree may be considered in lieu of relevant experience.

Experience in global clinical trial operations, including protocol development and key study documentation.

Demonstrated cross-functional team leadership, project management, and organizational skills.

Proven vendor management and budget management experience.

Strong understanding of ICH-GCP and applicable regulatory guidelines.

Technical proficiency with clinical trial systems, including CTMS, EDC, IWRS/IVRS, and Microsoft applications such as Teams, Office, and Project.

Strong communication, presentation, interpersonal, negotiation, and influencing skills.

Data-driven approach to planning, problem-solving, and decision-making, with the ability to prioritize and meet deadlines.

Ability to build productive teams, manage competing priorities, and stay current with industry trends.