Study Manager
Bayer Oy

Hae työpaikkaa
Alkuperäinen julkaisupäivä 11.1.2021

Bayer Oncology Strategic Business Unit is now looking for a professional with strong project management capabilities and interpersonal skills to work in Oncology Development Operations in a challenging global role based in Finland in Espoo as

 

STUDY MANAGER - ONCOLOGY

 

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
  • Manage external vendors
  • Responsible for developing and tracking the total external study budget and accountable for providing regular estimates information

 

WHO YOU ARE

  • Bachelor’s degree or Master’s degree in a Natural Science, Healthcare equivalent education plus about 7 years of relevant healthcare experience including 3 years clinical operations in the pharmaceutical industry which includes direct monitoring and clinical trial/study management experience, especially in Oncology
  • 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 January 24, 2021 via www.bayer.fi under "Meille töihin > Avoimet Työpaikat". Candidates will be reviewed on a continuous basis.

 

If this exciting role is just what you are looking for, we are keen to hear from you! For further information, please contact Tarja Jalava PhD, Head Clinical Project Management Oncology II, Oncology Strategic Business Unit by mobile: +358 40 523 0834 on Friday January 15th at 10.00 to 11.00 (EET).

 

Functional area: Clinical Development & Operations
Seniority level: Professional
#LI-NOR

 

 

 

Hae työpaikkaa

Lähetä ilmoitus kaverille

Lisätiedot