Senior Clinical Data Sciences Lead (Remote, Rockland or Billerica, MA)

Posted 24 Jun 2019

Billerica, Massachusetts - United States

Req Id 193915

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 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:

 

Providing project management expertise working with CRO data managers, key decision makers, and internal team members to manage all Data Management related activities in a clinical development program, issue escalation, workload projections and provide technical expertise. Managing continuous process improvements. Forecasting and monitoring program/project specific Global Clinical Data Sciences resources in collaboration with Global Clinical Data Sciences line management and Project Management.

 

Supervising surveillance of CRO activities regarding the quality and timeliness of the deliverables and ensure the database is ready for lock. Providing justification for and perform direct negotiations with CROs, e.g., timelines, financial, process, resources. Provide leadership to identify root causes of issues and implement remedial actions. Ensuring service and quality meet agreed upon specifications per the Integrated Data Management Plan and contract/Scope of Work.
 

Who you are:
 

Minimum Qualifications:

 

  • Bachelor’s degree with 8 plus years of experience, master’s degree with 3 plus years, or PhD experience required

 

Preferred Qualifications:

 

  • Advanced degree in Life Sciences (e.g. biology, chemistry, pharmaceuticals), Mathematics, Computer Sciences or comparable experience strongly desired
  • Excellent CDISC (SDTM) expertise
  • Good knowledge of SAS
  • Proven experience as Clinical Data Manager in the pharmaceutical/biotechnology industry, equivalent to 10 years strongly desired
  • Successful completion of multiple studies from beginning to end providing a full scope of DM experience
  • Proficiency with data management systems such as ClinTrial™, InForm™
  • Excellent Project Leadership expertise
  • Comprehensive knowledge of ICH-GCP, FDA regulations and Good Clinical Practice
  • Extensive knowledge of quality assurance
  • Proficient Computer Skills e.g. word processing, spreadsheets
  • Knowledge of medical terminology, Coding, SAE reconciliation

 

Position can be in Billerica, MA, Rockland, MA, or remote if you reside greater than a 50-mile radius from our Billerica and Rockland, MA, location.


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.



 

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