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Associate Director, Data Collection Standards (CDISC/CDASH) (all genders)

Your Role:

We are currently looking for an experienced Clinical Data Standards Expert with a deep knowledge in CDISC standards (CDASH & SDTM). The role leads the definition, development and governance of Clinical Data Collection Standards (CDISC/CDASH) including general and therapeutic area standards. It works closely with Medics, Safety, Biostatistics, Clinical Trial Management and other relevant stakeholders to continuously evolve the case report form library. As Associate Director Data Collection Standards you will implement and perform versioning, develop global standard CDASH case report form library and code lists. You work closely with the Common Protocol Template and SDTM governance leads to ensure alignment of the clinical data standards chain and work work closely with the Common Protocol Template and SDTM governance leads to ensure alignment of the clinical data standards chain.

The Position is located in our Global HQ in Darmstadt.

 

Who You Are:

•A minimum of 10 years of experience in pharmaceutical industry and processes with long professional experience in data management strongly preferred
•Bachelor's degree with 8 years of experience, or master's degree with 3 years of experience, or PhD in life sciences, mathematics or computer sciences or comparable professional experience minimum requirement
•A subject matter expert in CDISC (CDASH) and clinical data management
•Excellent CDISC expertise in SDTM and Controlled Terminology
•Comprehensive knowledge of ICH-GCP

Job Requisition ID:  194970
Location:  Darmstadt
Career Level:  E - Professional (10+ years)
Working time model:  full-time

US Disclosure
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.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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