Full Job Description
Clinical Study Associate Manager
Location: Armonk, NY, Warren, NJ
Travel percentage: May require 25% travel
May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with global study plans, and may contribute to global planning and management of the study
Contributes to risk assessment and helps identify risk mitigation strategies, and supports feasibility assessment to select relevant regions and countries
Oversees and provides input to the development of study specific documentation (e.g., CRF, data management plan, monitoring plan, monitoring oversight plan) and reviews site level informed consents and other patient-facing study start-up materials
Oversees setting up and maintenance of study systems including CTMS and TMF, and contributes to investigator meeting preparation and execution
Oversees engagement, contracting and management of required vendors for the study, and oversees and provides input to study drug and clinical supplies' forecasting, drug accountability and drug reconciliation
Provides regular status reports to collaborators as requested by the Clinical Study Lead, and contributes to development of and oversees implementation of recruitment and retention strategies
Monitors recruitment and retention, and monitors progress for site activation and monitoring visits
Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites, and escalates data flow and data quality issues to Clinical Study Lead
Oversees the execution of the specific clinical study deliverables against planned timelines, escalates issues related to timelines or budget to Clinical Study Lead, and supports accurate budget management and scope changes
Contributes to clinical project audit and inspection readiness throughout the study lifecycle, and supports internal and external inspection activities and contributes to CAPAs as required
Manages aspects of study close-out activities including database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability, may mentor clinical trial management staff, and may be assigned unmasked tasks for studies (e.g., unmasked TMF management, unmasked data review, IVRS point of contact)
This role requires:
Bachelor's Degree and 4+ years of relevant industry experience
Excellent communication and interpersonal skills; ability to build relationships internally and externally
A data driven approach to executing and problem solving, and attention to details for the ability to deliver on specific study activities
Technical proficiency in trial management systems and MS applications including Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF
Budget awareness with the ability to participate in various aspects of budget management
Familiarity with medical terms, and vendor management experience
Experience in clinical trial operations including experience developing key study documents
Knowledge of ICH/GCP and regulatory guidelines/directives
Salary Range (annually)
$109,900.00 - $179,300.00
