- Manages phase IV studies including
PMS as a Local Project Manager
- Maintains timely and
effective communication among team members, CRO and site staff. Routinely
anticipates/identifies potential issues and implements corrective actions
independently. Keeps project leadership apprised of team issues, seeking
guidance as needed. Demonstrates effective conflict resolution
- Responsible for site
management and site staff performance including: monitors all types of
clinical studies participates in all types of site visits assures
compliance with all protocol requirements assures effective patient
identification and recruitment plan is in place assures timely reporting of
Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations
ensures proper storage, dispensation, and accountability of all Investigational
Product(s) and study-related materials regularly reviews the status of the
contents of the site binder exhibits effective time management skills
- Organize and attends
Investigator meetings. May present materials, as requested. Manages with the
preparation of study start-up materials and tools, as requested. Attends
medical staff meetings, project team meetings, teleconference with oversea
colleagues, and internal/external clinical training sessions according to the
project communication, monitoring, and/or training plans
- Completes and submits
reports according to SOP/Operational Instructions (OI) or local regulations.
Maintains awareness of key study performance indicators for own sites, e.g.
Quality Review Visit Reports, patient enrollment, and SAEs. Updates study and
patient status information. Tracks Investigator payments/milestones.
Documents and tracks the resolution of all outstanding site-specific
protocol-related issues from visit to visit
- Conduct site monitoring
(including ICF check, source data verification, CRF/safety reports review,
study file review, study drug accountability check) to ensure that studies
are going well in accordance with protocol, GCP, relevant guidelines and
SOPs.
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