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

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 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.

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.

Quality, Risk & Compliance

• 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.

Vendor Oversight & Study Closeout

• 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.
• Travel may be required up to 25%.