(Poistunut julkaisusta)

Study Manager
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 MANAGER


YOUR TASKS AND RESPONSIBILITIES

• Manage all study related activities from an approved study concept to the final Clinical Study Report (CSR) to ensure study is conducted in high quality and within the given timeline and budget
• Identify, implement, lead and manage a global, cross-functional Study Team for the duration of the study, working with functional line management to identify team members and resolve issues
• Provide operational input and insight into the preparation of the study protocol and contribute to other core study documents
• Support study protocol feasibility; lead the operational planning and tracking of the site feasibility
• Support during Authority Inspections and internal audits and are responsible to get study conduct related findings solved
• Measure study performance using appropriate systems, tools and techniques
• Establish study milestones with the study team and ensure accurate tracking and reporting of study metrics such as recruitment projections, patient enrolment, data cleaning progress and overall study progress
• Lead study risk levelling and risk mitigation strategies
• Responsible for developing and tracking the total external study budget and accountable for providing regular estimates information


WHO YOU ARE

• Bachelor’s or Master’s degree in Natural Science, Healthcare or equivalent field
• Long-standing relevant healthcare experience including several years clinical operations in the pharmaceutical industry which includes direct monitoring and clinical trial/study management experience, specifically in Women’s Healthcare
• In-depth knowledge of Good Clinical Practices (GCP), federal regulations and international regulations (International Conference on Harmonization-ICH regulations) with a proven track-record leading the initiation and completion of clinical studies
• Comprehensive knowledge of the drug development process including, monitoring, regulatory requirements, drug safety requirements, data management processes and budget parameters
• Ability to successfully achieve results within a multi-cultural and geographically diverse team, and capability to create team culture and promote team spirit
• Effective planning and organization skills, attention to detail and excellent follow through
• 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 15 at 14.00–15.00 (EET) and Thursday November 21 at 10.00–11.00 (EET), phone +358 400 449053.

 

#LI-NOR