Clinical Trial Biosample Manager (m/f)

Posted 31 Aug 2018

Darmstadt, Hesse - Germany

Req Id 180937

Details

A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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 a Clinical Trial Biosample Manager you are responsible for the strategic and tactical operational delivery and execution of R&D sponsored programs and for all corporate sponsored programs for Phase I - Phase IV. You plan, implement, manage and drive biological sample logistics within our Institute Phase I-IV Clinical Trial. You advise on and deliver the Biosample strategy within multiple clinical programs in accordance with the requirements of quality, ethical and regulatory standards, including ICH/GCP/GLP. You are responsible for standardization and harmonization of Biosample activities across clinical trials and oversight of sample collection, processing, storage, and reconciliation; maximizing Biosample sample accrual and quality. You ensure project level consistency occurs for biosampling across studies and you are the primary point of contact within Clinical Trial Biosample Management for project, clinical, and study teams; contributing to innovation and improvement activities in collection, processing and data delivery.


Who you are:

  • Bachelor’s degree with 3 plus years or Master’s degree in life sciences (e.g. biology, chemistry, pharmaceutics) or related fields
  • At least 2 years of experience in clinical biosample project management preferred
  • Proficient in leading teams in a matrix organization and working on an international team
  • Advanced knowledge of ICH-GCP, other relevant Guidance documents (from ICH, FDA, EMEA etc.) and of regulations and requirements for clinical trial authorization, tissue storage and transfer in major countries
  • Project management skills, with a willingness to take on and lead special projects with the ablility to identify risks, problems, to propose appropriate measures when required is desirable
  • Willingness to travel (approx. 10% of time)


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!

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