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Clinical Trial Biosample Manager

Posted 02 Aug 2018

Billerica, Massachusetts - United States

Req Id 179928

Details

A career with EMD Serono 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. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.


Clinical Trial Management is responsible for the strategic and tactical operational delivery and execution of R&D sponsored programs for all corporate sponsored programs for Phase I - Phase IV.
 

Your role:

The Clinical Trial Biosample Manager plans, implements, manages and drives biological sample logistics within EMD Serono Research Development Institute Phase I-IV Clinical Trials, working with our Clinical Trial Management (CTM), under the leadership of the Head of Clinical Trial Biosample Management and Clinical Trial Leaders (CTLs).

The Clinical Trial Biosample Manager advises on and delivers the Biosample strategy within multiple clinical programs in accordance with the requirements of quality, and ethical and regulatory standards, including ICH/GCP/GLP. Ensures standardization and harmonization of Biosample activities across clinical trials and oversight of sample collection, processing, storage, and reconciliation; maximizing Biosample sample accrual and quality.

Responsible for ensuring ethical use of biosamples collected in EMD Serono Research Development Institute clinical trials. Ensures project level consistency occurs for biosampling across studies and is 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 field
  • 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 and tissue storage and transfer in major countries
  • Project management skills, with a willingness to take on and lead, special projects with the able to identify risks, problems, and 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!

 

Curious? Apply and find more information at come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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