Sr. Clinical Study Lead (SCSL)

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

Job summary

KPS Life is seeking a Sr. Clinical Study Lead to drive global trials from planning through closeout, leading cross-functional teams, CROs, and budgets, while ensuring data quality and regulatory compliance.

The role requires expertise in ICH-GCP, protocol development, vendor management, and monitoring of complex studies across regions, with a hybrid work model in Cambridge, MA; Armonk, NY; or Warren, NJ.

Qualifications

• Bachelor's degree or equivalent and at least 8 years of relevant industry 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 (CTMS, EDC, IWRS/IVRS) and common software like Teams, Office, and Project.

Responsibilities

• 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.
• 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 (CTMS, 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 regulatory compliance.
• 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.

Skills

Cross-functional leadership

Project management

Organizational skills

Vendor management

Budget management

ICH-GCP knowledge

CTMS

EDC

IWRS/IVRS

Teams / Office / Project

Communication

Presentation

Interpersonal skills

Negotiation

Data-driven planning

Team-building

Education

Bachelor's degree

Advanced degree

Tools

CTMS

EDC

IWRS/IVRS

Teams

Office

Project

Job description

Sr. Clinical Study Lead (SCSL) - (Warren, NJ, Armonk NY, or Cambridge, MA)

Warren, NJ, Armonk, NY or Cambridge, MA

Opportunity Details

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

KPS Life is hiring a Sr. 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 strong study leadership, vendor management, and global trial experience.

Interested in learning more? Let’s connect!

Senior Clinical Study Lead (Sr. CSL)

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

Position Overview

The Senior Clinical Study Lead (Sr. 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 8 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.