SEND Project Manager (all genders)

Posted 18 Jul 2019

Darmstadt, Hesse - Germany

Req Id 194935

Details

A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your role:

As SEND (Standard for Exchange of Non-clinical Data) project manager you are an integral member of the Chemical and Preclinical Safety Team and work closely with the study directors/study monitors, external SEND conversion vendors, CROs and consultants. The coordination of the operational SEND activities for internal and external studies is one of your main responsibilities. As the leader of the SEND team you are the first point of contact for all SEND-related questions. In addition, you efficiently drive the finalization of the on-going SEND implementation project, which directly impacts our submission readiness. This includes keeping the SEND processes and stakeholders aligned to current and future requirements regarding SEND by liaising with relevant stakeholders, SEND-related organizations and the FDA. Overall you ensure that the SEND data packages and processes are compliant with relevant guidelines/regulations (e.g., CDISC, SEND IG, FDA Business Rules), budget and timelines.

 

Who you are:

  • Graduate or master´s degree in life sciences or proven experience in (non-clinical) data management, ideally experience with SEND
  • Prior project leader/management experience
  • Experience in creation/handling of CDISC datasets and standards, preferable SEND
  • Good background in SEND relevant guidelines and regulations (e.g., CDISC, SEND IGs, FDA Business Rules, TCG)
  • Fluency in written and spoken English combined with a sense of organizational psychology which allows to meet people where they are

What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

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