A career with EMD Serono is an ongoing journey of discovery: our 57,000 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. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your role:
The Biosample Operations Manager (BOM) will act as the SME for all biological samples collected during the clinical trial. You will be responsible for the Biosample operational implementation and execution of the translational medicine strategy (e.g. Biomarker/CDx, PK, ADA) in an assigned clinical trial. You will also maintain a patient focus to balance the value of samples versus the complexity of collection, cost to the trial and potential affects upon patient recruitment and burden. You will be responsible for 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. You will review and provide input regarding operational feasibility for relevant clinical documents and/or answering regulatory questions concerning operational activities. You'll act as single point of contact regarding all Biomarker/PK/ADA operational aspects within the Clinical trial team. You will manage the interface between Global Clinical Operations (GCO), non-GCO functions and External partners (e.g. CRO, Analytical Labs) to ensure proper planning and cross-functional alignment on deliverables and timelines.
Who you are:
Minimum Qualifications:
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