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

kps life; Warren (MA); Hybride; USD 130 000 - 180 000; Plein temps

Résumé du poste

KPS Life is seeking a Sr. Clinical Study Lead to lead global trials from planning through closeout, overseeing study execution, timelines, budgets, CROs, and quality. This role requires strong study leadership, vendor management, and global trial experience.

This hybrid position supports three days per week in sponsor offices (Armonk, NY; Warren, NJ; Cambridge, MA) with significant cross-functional collaboration and travel up to 25% to ensure program success.

Qualifications

• Bachelor's degree or equivalent; 8+ years in global clinical trial operations.
• Experience leading cross-functional study teams and CRO oversight.
• Strong vendor and budget management; ICH-GCP knowledge.
• Technical proficiency with CTMS, EDC, IWRS/IVRS; MS Teams and Office.
• Excellent communication, planning, and problem-solving skills.

Responsabilités

• Lead cross-functional study teams and act as key point of contact for study leadership.
• Provide operational input into protocol development and key study documents.
• Oversee feasibility assessments, country selection, site evaluation, and investigator meetings.
• Oversee study timelines, milestones, site activation, monitoring, recruitment and retention strategies.
• Manage study budgets, vendor contracts, scope changes, and drug supply forecasting.
• Oversee CTMS, TMF, data entry and query resolution.
• Lead study-level risk assessments and mitigation strategies.
• Monitor data quality, protocol deviations, and site compliance.
• Support audits and inspections readiness, CAPAs, and regulatory compliance.
• Lead vendor engagement and oversee CRO performance; drive issue resolution.
• Oversee closeout activities including database lock, TMF completion, drug accountability, and study report review.

Connaissances

Cross-functional leadership

Project management

Vendor management

Budget management

ICH-GCP

Communication

Data-driven planning

Problem-solving

Team building

Travel readiness

Formation

Bachelor's degree

Outils

CTMS

EDC

IWRS/IVRS

Microsoft Teams

Microsoft Office

Project

Description du poste

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.

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 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.
• Travel may be required up to 25%.