Associate Director Data Standards, CRF and Non-CRF Data Collection
EMD Serono

Job Info

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A career with EMD Serono is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role:

An exciting opportunity has arisen to join our healthcare business to support the development of first and best in class specialty medicines for our patients in need. As Associate Director Data Standards, CRF and Non-CRF Data Collection you will lead standardization of clinical data collection. You will also ensure ongoing maintenance of developed standards as part of a holistic company-wide library and support implementation of standards by internal and external stakeholders.

• Collaborative leadership and facilitation of company-wide cross functional Clinical Data Standards Governance Team with CRF/Non-CRF Data Collection and SDTM Standards Leads.
• Ensures harmonization of Data Collection Standards with SDTM Standards and company tools/system requirements in collaboration with CRF/Non-CRF Data Collection and SDTM Standards Leads.
• Drives strategic and fit for purpose development of standards to support data collection requirements; including but not limited to specification of expected dataset record structure, variables, and controlled terminology in alignment with downstream SDTM and other dataset formats.
• Leads evaluation and resolution of proposed changes to CRF/Non-CRF Data Collection Standards content and metadata.
• Supports adoption and implementation of CRF/Non-CRF Data Collection Standards; including development of company-wide training and provision of consultancy when needed to both internal and external stakeholders using standards.
• Collaborative development of standards management strategy and ongoing maintenance of standards in the company-wide library.
• Acts as a clinical data standards Subject Matter Expert (SME) supporting initiatives/projects related to data workflow, processes, and tools.

Who You Are:

Minimum Qualifications:

• Bachelor's degree in relevant life science, data science, or analytical area with 8+ years relevant experience or Master's degree with 5+ years relevant experience.
• Expert understanding of CDISC standards; including but not limited to CDASH, SDTM, Controlled Terminology, as well as other standards and tools.
• Demonstrated leadership with ability to manage teams and inspire stakeholders to achieve standards development and implementation goals.
• Ability to build strong professional relationships across the organization.
• In depth knowledge of regulatory requirements, additional industry standards, and industry best practices for clinical data standards development and implementation.
• Advanced understanding of data collection systems and tools including electronic case report forms and data transfer agreements.
• Working knowledge of data management and other research and development best practices supporting clinical research.
• Excellent verbal and written communication skills.

Preferred Qualifications:

• Experience programming SDTM datasets from non-CRF and other data sources preferred.

Travel Requirements:

• Some travel may be required, including overnight and international travel to other company sites and/or to meet with strategic partners.

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 athttps://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.

Job Requisition ID: 222280

Location: Billerica

Career Level: D - Professional (4-9 years)

Working time model: full-time

This job has expired.