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Head of Clinical Data Standards & Governance

Company: Merck KGaA
Location: Billerica
Posted on: June 7, 2021

Job Description:

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.

Your role:

an exciting opportunity has arisen to join our healthcare business to drive the development of first and best in class specialty medicines for our patients in need. As our Head of Clinical Data Standards & Governance, you will be leading a global team of Data Standards Experts who are responsible for driving all Data Standards and Governance related activities for the complete clinical development portfolio. This includes the development of the Clinical Data Standards Strategy including responsibility for data collection standards (CRF, CDASH), external data standards and our CDISC-SDTM standards. While driving the collaboration with our CRO partners, you will ensure the quality of CRO deliverables regarding Data Standards (including CDISC-STDM). By Developing and implementing innovative data standards tools, systems and processes your team will ensure submission readiness. Together with the Global Clinical Data Sciences leadership team, you will define the Clinical Data Management strategy.

Who you are:

Minimum qualifications:

  • Advanced Degree in a scientific discipline or health related field (e.g. life sciences, mathematics, computer science) with experience in the area of clinical data management and clinical data standards (10+ years); Business and management background (MBA) is a plus
  • Profound experience as an innovative senior line manager (5+ years) incl. managing global teams, demonstrating inspirational leadership, motivation and team building skills
  • Excellent knowledge in the area of clinical data standards (CRF, CDISC-SDTM, external data standards)

Preferred qualifications:

  • Excellent understanding of regulatory requirements, guidelines and trends (e.g. ICH, FDA, EMA, PMDA)
  • Excellent knowledge of data management tools and systems like EDC (e.g. Oracle Inform, Medidata Rave), clinical data repositories, data standards metadata repositories, Pinnacle 21, etc., advanced programming experience (SAS, R, etc.) 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

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.

Keywords: Merck KGaA, Billerica , Head of Clinical Data Standards & Governance, Other , Billerica, Massachusetts

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