On-Site CSAM: Lead Clinical Study & Vendor Oversight

KPS Life; New York (NY); On-site; USD 100,000 - 135,000; Full time

Job summary

KPS Life is seeking a Clinical Study Associate Manager to support clinical trial delivery for a sponsor partner. The CSAM will work on-site three days a week at Warren, NJ or Armonk, NY, with Warren preferred, collaborating with CROs and internal teams to ensure study milestones are met and data integrity is maintained.

The role requires strong experience with EDC/Rave, Veeva, CTMS, and TMF, plus knowledge of ICH/GCP and CFRs. Prior CRA experience is a plus for site and data reviews.

Qualifications

• Bachelor’s degree required; 4+ years in clinical research/operations.
• Strong hands-on experience with EDC (Rave) and CTMS; familiarity with TMF systems.
• Experience with Veeva and TMF systems preferred; CRO oversight experience a plus.
• Proven ability to manage data quality, site monitoring, and study timelines.

Responsibilities

• Lead or oversee planning and management of studies within assigned regions.
• Contribute to risk assessments and mitigation strategies.
• Support feasibility and selection of regions/countries for studies.
• Oversee study documentation development (CRFs, DMP, Monitoring Plans).
• Review site-informed consent and startup materials; ensure regulatory compliance.
• Oversee CTMS/TMF setup and maintenance; monitor vendor deliverables.

Skills

EDC/Rave

Veeva

CTMS

TMF

CRO oversight

Data cleaning

Data quality

Budget management

Regulatory knowledge

GCP/ICH

Cross-functional collaboration

Education

Bachelor’s degree

Tools

IWRS/IVRS

EDC systems (Rave)

Job description

KPS Life is seeking a Clinical Study Associate Manager to support clinical trial delivery for a sponsor partner. The CSAM will work on-site three days a week at Warren, NJ or Armonk, NY, with Warren preferred, collaborating with CROs and internal teams to ensure study milestones are met and data integrity is maintained.

The role requires strong experience with EDC/Rave, Veeva, CTMS, and TMF, plus knowledge of ICH/GCP and CFRs. Prior CRA experience is a plus for site and data reviews.