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Study Lead Monitor

Posted on Dec 13, 2018 by Experis IT

Reading, Berkshire United Kingdom
Health Care
Immediate Start
£380 - £380 Daily
Contract/Project

Study Lead Monitor
Reading
Start date 1/3/19 (3-6 months)
Pay: up to £380 per day

Job Purpose:

The Study Lead Monitor (SLM) is a core member of the Study Team and in this role responsible and accountable for representing and overseeing all aspects of the monitoring and site management activities including country performance matters for the assigned global clinical trials for Clinical Development and Medical Affairs

Key Responsibilities:

1. LEADERSHIP

  • Leads and motivates the geographically dispersed Country Lead Monitors (CLMs) and Clinical Research Associates (CRAs) assigned to a given study
  • Leads regular CLM meetings and contributes to regular Core Team Meetings
  • As a core member of the Study Team, the SLM works in close collaboration with the StM and the Study Team

2. COLLABORATION and CONTRIBUTION

  • Represents monitoring and site management aspects in the Core Study Team
  • Works in close collaboration with the Country teams, StM, Study Data Manager (SDM), EDC Developer, Study Medical Expert (SME), IxRS and Medication Manager (IMM) and other functions

3. TRAINING

  • Responsible and accountable for the study specific training and quality oversight of monitoring and site management activities for the assigned study

4. TRACKING AND REPORTING

  • As a Core Team Member of the Global Study Team (GST), SLM ensures proper tracking of monitoring and country relevant topics and provides StM with information required to accurately track and manage study activities
  • Reviews Country Monthly Reports, tracks operational study activities and progress, and consolidates information as required by StM
  • In partnership with SDM, tracks and manages patient data review, verification and cleaning process to ensure continuous and current flow of data cleaning

5. PREPARATION OF DOCUMENTS

  • Responsible and accountable for developing the Monitoring Plan and appendant study specific forms, and substantially contributes to the development of recruitment and retention strategies and tools
  • Contributes to the protocol and study and oversight plan development with regard to monitoring and operational aspects
  • Member of the Study Data Acquisition and Management Package Development Team (SDAMP-DT) and works closely with the EDC Developer in developing the eCRF, edit checks and eCRF instructions

6. QUALITY, RISK IDENTIFICATION AND HANDLING

  • Conducts co-monitoring visits as specified in the study oversight plan
  • Is an active member of the Fraud & Misconduct Team and Serious Breach Team as applicable
  • Escalates identified issues appropriately to ensure timely corrective and preventive actions are taken as required

Qualifications/Ideal Candidate:

  • Bachelor's degree
  • Knowledge of Good Clinical Practices (GCP) & international regulations
  • Knowledge of the drug development process including monitoring and site management, regulatory requirements, drug safety requirements, and data management processes

Reference: 599558500