Biosample Operations Manager
EMD Serono

Job Info

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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:

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

Preferrred Qualifications:

• PhD in Biology, Pharmaceuticals or other Science discipline strongly preferred
• 4+ years clinical operations experiences and a minimum of 2+ years experiences with clinical Biomarker/Biosample processes
• Certification in Clinical Research or Bachelor or Masters' degree in Clinical Research/Clinical Trial Management

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

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Job Requisition ID: 217501

Location: Billerica

Career Level: D - Professional (4-9 years)

Working time model: full-time

This job has expired.