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

Clinical Study Associate Manager (CSAM) Warren, NJ or Armonk, NY jobs in United States

Tags

25 applicants

Original Job Post

kps life

+1 more

79

GOOD MATCH

Experience Level

65

Skill

Industry Exp.

75

KPS Life

Responsibilities

May lead or oversee the planning and management of a clinical study in assigned region(s), in alignment with global study plans, and may contribute to global study planning and management

Contribute to risk assessments and help identify appropriate risk mitigation strategies

Support feasibility assessments and selection of relevant regions and countries

Oversee and provide input into the development of study-specific documentation, including but not limited to Case Report Forms (CRFs), Data Management Plans, Monitoring Plans, and Monitoring Oversight Plans

Review site-level informed consents and other patient-facing study start-up materials

Oversee the setup and ongoing maintenance of study systems, including Clinical Trial Management Systems (CTMS) and Trial Master File (TMF) systems

Support investigator meeting preparation and execution

Oversee the engagement, contracting, and management of required study vendors

Provide CRO oversight and monitor vendor deliverables, timelines, and quality

Oversee and provide input into study drug and clinical supplies forecasting, drug accountability, and drug reconciliation

Provide regular study status reports to stakeholders as requested by the Clinical Study Lead

Contribute to the development and oversight of recruitment and retention strategies

Monitor progress for site activation and monitoring visits

Support data quality through regular review of data metrics, listings, protocol deviations, eligibility violations, dosing deviations, and suspected site non-compliance

Support data cleaning activities and identify and escalate data flow or data quality issues to the Clinical Study Lead

Review monitoring visit reports and identify potential site, study, or data-related issues. Previous CRA or clinical monitoring experience is highly desirable

Oversee execution of specific clinical study deliverables against planned timelines

Escalate issues related to timelines, quality, or budget to the Clinical Study Lead

Support accurate budget management and scope changes

Contribute to clinical project audit and inspection readiness throughout the study lifecycle

Support internal and external inspection activities and contribute to CAPAs as required

Manage aspects of study closeout activities, including but not limited to database lock, vendor contract reconciliation, study budget, TMF, and study drug accountability

Support activities associated with database lock and final data cleaning

Work effectively across multiple clinical systems and data sources in a fast-paced study environment

May be assigned unmasked tasks for studies, which may include but are not limited to assisting with masked investigational product, setting up and managing an unmasked Trial Master File, reviewing unmasked data in the electronic data capture system, serving as a point of contact for IVRS/IWRS issues, and supporting oversight of unmasked clinical monitoring

Benefits

On-site 3 days per week in either Warren, NJ or Armonk, NY

Clinical trial functional service provider for pharmaceutical sponsors.

Malvern, Pennsylvania, USA

http://www.kpslife.com/

Late Stage

Total Funding

$2.96M

2026-09-01

Undisclosed· $0.66M

2025-06-11

Undisclosed· $2.3M

2021-02-26

Debt Financing

Leadership Team

Kevin Duffy

Chief Commercial Officer

Recent News

GlobeNewswire

ForFarmers N.V.: Trading update Q1 2026

2026-05-07

Pharmafile

Quanticate announces strategic partnership with KPS Life

2023-06-05

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Qualifications

Bachelor's degree and a minimum of 4 years of relevant clinical research or clinical operations experience

Technical proficiency in clinical trial systems and Microsoft applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, and IWRS/IVRS

Strong hands-on experience with Electronic Data Capture (EDC) systems; Rave experience is highly desirable

Experience with Veeva and Trial Master File (TMF) systems strongly preferred

Previous CRA or clinical monitoring experience is highly desirable, particularly experience reviewing monitoring visit reports and identifying site or study issues

Experience supporting data review, data cleaning, and activities leading to database lock

Experience with CRO oversight and external vendor management

Experience working with laboratory and IRT/IWRS vendors is a plus

Strong technical aptitude and ability to quickly learn and navigate multiple clinical systems

Knowledge of ICH GCP and relevant regulatory guidelines/directives

Demonstrated interpersonal and leadership skills

Exceptional attention to detail and ability to deliver high-quality study activities within established timelines

Proactive and self-disciplined, with the ability to meet deadlines, manage priorities, and use time effectively

Effective communication skills, both verbal and written, with strong presentation skills

Ability to work collaboratively with cross-functional teams, CROs, sites, and external vendors

Bachelor’s degree and a minimum of 4 years of relevant clinical research or clinical operations experience.

Required skills

Clinical Trial Systems, Electronic Data Capture (EDC), Rave, Veeva, Trial Master File (TMF) Systems, Clinical Trial Management Systems (CTMS), IWRS/IVRS, Microsoft Office, Microsoft Project, Clinical Monitoring, Data Cleaning, Database Lock, CRO Oversight, External Vendor Management, ICH GCP

Experience

4+ years