A career with EMD Serono is an ongoing journey of discovery: our 51,000 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.
EMD Serono is currently looking for an experienced Clinical Data Standards Expert with a deep knowledge in CDISC standards (CDASH & SDTM).
- Lead the definition, development and governance of Clinical Data Collection Standards (CDISC/CDASH) including general and therapeutic area standards
- Work closely with Medics, Safety, Biostatistics, Clinical Trial Management and other relevant stakeholders to continuously evolve the case report form library
- Develop and implement training curriculum to study team members
- Work closely with Data Management and CROs to ensure data standards are adopted in EDC study configuration
- Provide adherence to data standards results to stakeholders (e.g. Data Standards Governance Committee)
- Analyze data standards adherence and define means to improve CDASH case report form library
- CDASH – Implement and perform versioning; develop global standard CDASH case report form library and code lists
- Work closely with the Common Protocol Template and SDTM governance leads to ensure alignment of the clinical data standards chain
- Review and evolve Edit Checks in line with the existing company CDASH case report form library
- Monitor releases of Standard Development Organizations (e.g. CDISC)
- Support the adoption of external standards
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.
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
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.