Country Lead Monitor
Bayer Türk Kimya Sanayii Ltd Şti
İstanbul(Asya)
20.08.2020
• The incumbent must have a Undergraduate degree’ (Life Sciences or equivalent) with 5 years of relevant healthcare experience including 4 years monitoring & site management experience or 2 years of clinical trial management experience.
• Core Competencies: Customer focus; Drive Results; Plan & Align; Manage Complexity
• Leadership Competencies: Build Effective teams; Cultivate Innovation; Courage
• Functional Competencies: Deep knowledge of R&D processes and local &global regulations; Project management skills; Decision-making and issue resolution skills; Cross-Functional collaboration; Budget management
• Effective written and verbal English communication skills; Turkish is a must
Job Description
• The Country Lead Monitor (CLM) is the key country study contact for the core study team and overall responsible for country deliverables regarding timelines, budget and quality for assigned studies from feasibility all the way through archiving. The CLM is the leader of the local study team, and also the main contact across other functions locally.
• The CLM performs monitoring report review and ensures follow up items are resolved according to SOPs / OI. The CLM regularly conducts co-monitoring visits to ensure the quality of the study.
• As a member of the audit/regulatory inspection team, the CLM is a key contributor to the preparation, conduct and follow up of site audits and regulatory inspections to ensure a successful outcome.
• The CLM develops the country enrollment, retention and contingency plans, manages country site selection and initiation, country risk leveling, patient enrollment and data cleaning activities.