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

KPS Life is hiring a Clinical Study Associate Manager to be fully dedicated to one of our sponsor partners and work on-site 3 days per week in either Warren, NJ or Armonk, NY (Warren preferred).

We’re looking for a strong clinical operations professional with experience in EDC/Rave, Veeva, CTMS and TMF, who is comfortable working with high volumes of clinical data and supporting data cleaning and database lock activities. Prior CRA experience is a plus, particularly experience reviewing monitoring visit reports and identifying study or site issues. Experience with CRO and vendor oversight and strong technical skills are also important for this role.

If you’re looking for an opportunity to work closely with a sponsor team and take on meaningful study responsibilities, we’d love to hear from you.

The Clinical Study Associate Manager (CSAM) supports the Clinical Study Lead by taking responsibility for key areas of clinical trial delivery. The CSAM works closely with internal study teams and external vendors, including CROs, throughout feasibility, planning, initiation, maintenance, and closeout of clinical projects.

The CSAM performs activities in accordance with GCP, ICH, applicable CFR requirements, and the Client’s Standard Operating Procedures (SOPs). This role applies to both internally sourced studies and studies outsourced to Clinical Research Organizations (CROs), with the balance of direct execution and CRO oversight varying by study.

The Clinical Study Associate Manager Will

• 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…