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

About the role

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.

Responsibilities

• 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.

Requirements

• 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