Hybrid Clinical Study Manager — Global Trials

KPS Life; Cambridge (MA); Hybrid; USD 110,000 - 160,000; Full time

Job summary

KPS Life is seeking a Clinical Study Associate Manager (CSAM) to oversee study planning, execution, and closeout across sponsor partnerships. The role requires collaboration with internal study teams and CROs to ensure timelines, quality, and regulatory compliance in a hybrid work model across Warren, NJ, Armonk, NY, or Cambridge, MA.

The CSAM will lead study planning, monitor vendors, manage budgets, and ensure SOP/ICh-GCP adherence, with strong attention to detail and leadership potential.

Qualifications

• Bachelor’s degree and at least 4 years of relevant experience.
• Knowledge of ICH-GCP and applicable regulatory guidelines.
• Proficiency with CTMS, EDC, IWRS/IVRS, and Microsoft Office.

Responsibilities

• Support regional study planning and management in alignment with global study plans.
• Contribute to feasibility assessments, risk evaluations, and risk mitigation strategies.
• Support site activation, monitoring visits, investigator meetings, and recruitment and retention strategies.
• Provide study status updates to stakeholders and help ensure deliverables meet planned timelines.
• Oversee study documents, including CRFs, data management plans, monitoring plans, and monitoring oversight plans.

Skills

ICH-GCP

CTMS

EDC

IWRS/IVRS

Microsoft Office

Project

Attention to detail

Leadership

Communication skills

Education

Bachelor's degree

Job description

KPS Life is seeking a Clinical Study Associate Manager (CSAM) to oversee study planning, execution, and closeout across sponsor partnerships. The role requires collaboration with internal study teams and CROs to ensure timelines, quality, and regulatory compliance in a hybrid work model across Warren, NJ, Armonk, NY, or Cambridge, MA.

The CSAM will lead study planning, monitor vendors, manage budgets, and ensure SOP/ICh-GCP adherence, with strong attention to detail and leadership potential.