Clinical Study Associate Manager (CSAM) (Warren, NJ, Armonk, NY or Cambridge, MA)

kps life; Warren (MA); Hybrid; USD 110,000 - 150,000; Full time

Job summary

KPS Life is seeking a Clinical Study Associate Manager (CSAM) dedicated to our sponsor partner. The role is hybrid, three days per week, in Armonk NY, Warren NJ, or Cambridge MA, supporting global clinical trial delivery from planning to closeout.

You will work with Clinical Study Leads, cross-functional teams, and CROs to ensure milestones, quality, and regulatory compliance. A minimum of four years' experience in clinical research is required.

Qualifications

• Bachelor's degree and at least 4 years of relevant experience.
• Knowledge of ICH-GCP and applicable regulatory guidelines.
• Proficiency with clinical trial systems (CTMS, EDC, IWRS/IVRS) and Microsoft Office tools.
• Strong attention to detail and the ability to manage study activities accurately.
• Excellent communication, presentation, interpersonal, and leadership skills.
• Proactive, self-disciplined, with strong time management and budgeting awareness.

Responsibilities

• Support regional study planning and management in alignment with global study plans.
• Contribute to feasibility assessments, risk evaluations, and mitigation strategies.
• Assist in site activation, monitoring visits, investigator meetings, and recruitment strategies.
• Provide study status updates to stakeholders and ensure deliverables meet timelines.
• Develop and review study documents and oversee CTMS and TMF-related activities.
• Support vendor engagement, contracting, and ongoing management.
• Assist with study budget management and forecasting, including drug accountability.

Skills

Attention to detail

Communication skills

Time management

Leadership

Cross-functional collaboration

Education

Bachelor's degree

Tools

CTMS

EDC

IWRS/IVRS

Teams

Office

Project

Job description

KPS Life is hiring a Clinical Study Associate Manager (CSAM) 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 supports global clinical trial delivery from study planning through closeout, working closely with Clinical Study Leads, cross-functional teams, and CROs. We’re looking for a detail-oriented clinical research professional with at least 4 years of relevant experience and knowledge of clinical trial operations.

Hybrid 3 days a week in Warren, NJ, Armonk, NY or Cambridge, MA

Position Overview

The Clinical Study Associate Manager (CSAM) supports the Clinical Study Lead in delivering clinical trials from feasibility and planning through initiation, maintenance, and closeout. This role partners with internal study teams and external vendors, including CROs, to support study timelines, quality, and compliance with SOPs, ICH-GCP, and applicable regulatory requirements. Responsibilities include direct study execution and oversight of CRO deliverables.

Key Responsibilities

Study Planning & Execution

• 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.

Study Documentation & Systems

• Contribute to the development and review of study documents, including CRFs, data management plans, monitoring plans, and monitoring oversight plans.
• Review site-level informed consent forms and other patient-facing startup materials.
• Oversee study systems, including CTMS and TMF, and support ongoing maintenance and documentation quality.

Vendor, Budget & Clinical Supplies Oversight

• Support vendor engagement, contracting, and ongoing management.
• Contribute to study budget management and scope changes.
• Oversee clinical supply forecasting, drug accountability, and reconciliation.
• Escalate timeline, budget, data flow, and data quality issues to the Clinical Study Lead.

Quality, Compliance & Study Closeout

• Review data metrics, listings, protocol deviations, eligibility violations, dosing deviations, and potential site non-compliance.
• Support audit and inspection readiness throughout the study lifecycle, including CAPAs as needed.
• Manage assigned closeout activities, including database lock, vendor contract reconciliation, budget review, TMF completion, and study drug accountability.
• Support unmasked study activities when assigned, which may include unmasked TMF management, EDC data review, IVRS issue resolution, and monitoring oversight.

Requirements & Qualifications

• Bachelor’s degree and at least 4 years of relevant experience.
• Knowledge 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 attention to detail and the ability to manage specific study activities accurately.
• Effective communication, presentation, interpersonal, and leadership skills.
• Proactive and self-disciplined, with strong time management, prioritization, and deadline management skills.
• Budget awareness and the ability to contribute to study budget management.