Hybrid Global Clinical Study Lead — Complex Trials

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

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.