Merck KGaA

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Originele vacaturetekst

Senior Manager Biosample Operations (all genders) - part-time possible

A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role:

The Biosample Operations Lead (BOL) will act as the subject matter expert for all biological samples collected during the clinical trial. The BOL is responsible for the Biosample operational implementation and execution of the translational medicine strategy (e.g. Biomarker/CDx, PK, ADA) in an assigned clinical trial. The BOL maintains a patient focus to balance the value of samples versus the complexity of collection, cost and potential affects upon patient recruitment and burden. Responsibility of overseeing the business process of Biosample lifecycle to ensure that the samples are collected, processed, analyzed and stored with the highest degree of quality and according to applicable regulations. Responsibility of reviewing and providing input regarding operational feasibility for relevant clinical documents and/or answering regulatory questions concerning operational activities. Acting as single point of contact regarding all Biosample operational aspects within the Clinical trial team and responsible for managing the interface between internal functions and External partners (e.g. CRO, Analytical Labs) to ensure proper planning and cross-functional alignment on deliverables and timelines.

Who you are:

  • PhD in Biology / Pharmaceuticals / Science

  • Depending on experience level, Bachelor’s degree in Biology, Pharmaceuticals or other Science discipline with 3+ years of experience in clinical operations, or Master’s degree in Biology, Pharmaceuticals or other Science field

  • 4+ years clinical operations experiences and a minimum of 2+ years experiences with clinical Biomarker/Biosample processes

  • Proven experience in Biosample- and central lab management

  • Sound experience in reviewing/commenting/revising clinical Essential Documents (e.g. CTP, ICF, PIS, Lab Manual)

  • Sound knowledge in Project Management Technics

  • Certification in Clinical Research would be an added value

  • Knowledge in some therapeutic areas (e.g. oncology, immunology)

  • Excellent command of English language (verbally and in writing); other language(s) is a plus

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

Art des Stellenangebotes:
Intern

Fähigkeiten

  • Es ist kein Abschluss erforderlich