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

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

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

Warren, NJ, Armonk, NY or Cambridge, MA

Opportunity Details

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

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.

Clinical Study Associate Manager (CSAM)

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.