Serves as the primary site manager for assigned clinical investigative sites
Manages assigned study sites/networks, conducts phase I-IV protocols according to the monitoring plan
Facilitates the preparation and collection of site and country level documents
Performs Site Initiation Visit, ensures site personnel are fully trained on all trial related aspects
Conducts continuous monitoring activities (onsite and/or remote)
Monitors studies as per current legislations, ICH/GCP and Novartis standards
Collaborates with internal stakeholders and site personnel to manage data query resolution process

Requirements

BS/BA degree in Scientific, Healthcare or related field
Excellent knowledge of the drug development process specifically clinical trial/research
Knowledge of international standards (GCP/ICH, FDA, EMEA)
Minimum of 3 years’ experience in site monitoring strongly preferred
RLT, CAR T or Oncology experience a plus!
Fluent in both written and spoken English

Benefits

Health, life and disability benefits
401(k) with company contribution and match
Generous time off package including vacation, personal days, holidays and other leaves
Performance-based cash incentive

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

site monitoringclinical trial managementdata query resolutionphase I-IV protocolssite initiation visitdrug development processclinical research

Soft Skills

collaborationcommunicationtraining