(Poistunut julkaisusta)

Study Lead Monitor
Bayer Oy

Alkuperäinen julkaisupäivä 12.11.2019

We are now looking for a professional with strong project management capabilities and interpersonal skills to work in Clinical Development Operations in a challenging global role based in Finland in Espoo as


STUDY LEAD MONITOR


YOUR TASKS AND RESPONSIBILITIES

• Responsible to represent and oversee all aspects of monitoring and site management activities including legal and regulatory requirements
• Lead and motivate the geographically dispersed Country Lead Monitors (CLMs) and Clinical Research Associates (CRAs) assigned to the study
• Representative for monitoring and study center management aspects in the global Study Team
• Responsible for study specific training and quality oversight of monitoring and site management activities
• Ensure tracking of monitoring and country relevant issues
• Responsible for the development of the monitoring plan and associated specific study forms
• Contribute to the development of monitoring strategy, study risk levelling and preparation of audits and inspections by authorities
• Perform and co-ordinate co-monitoring visits including review of monitoring reports as specified in the study quality plans


WHO YOU ARE

• Minimum Bachelor’s degree in a Natural Science, Healthcare or equivalent field
• Several years of professional experience in healthcare, monitoring and trial center management including specific experience in the indication Women’s Health
• Several years of experience in CLM country project management and experience as global Study Lead Monitor
• Profound knowledge of Good Clinical Practices (GCP) and international regulations
• Comprehensive knowledge of drug development process including monitoring, regulatory requirements, drug safety requirements and data management
• Ability to weigh risks and benefits of different solutions against each other
• Willingness to question circumstances and drive change forward
• Effective written and verbal communication, thorough knowledge of oral and written English


We offer a competitive compensation, independent and challenging role in an international environment with a chance to develop your skills and expertise further. To be considered for this exciting opportunity, please submit your application by Sunday November 24, 2019 via www.bayer.fi under "Meille töihin > Avoimet Työpaikat". Candidates will be reviewed on a continuous basis.

If you feel this unique role is just what you are looking for, we are keen to hear from you! For further information, please contact Jutta Lindborg, Strategic Initiatives Project Leader, Friday November November 15 at 15.00–16.00 (EET) and Thursday November 21 at 9.00–10.00 (EET), phone +358 400 449053.

 

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