Associate Director, Global Clinical Data Standards

MSD; Kraków; Presencial; PLN 559.000 - 880.000; Jornada completa

Descripción de la vacante

Merck & Co., Inc. seeks an Associate Director to lead data collection data stewardship within Global Data Management and Standards (GDMS) and Global Clinical Data Standards (GCDS). The role guides study teams on data standards, library use and governance, while driving new/modified standards and processes.

Responsibilities include leading Therapeutic Area Standards Teams, delivering training, supporting information governance, tracking conformance, and mentoring staff across global teams.

Formación

• Must have extensive clinical data management or standards experience.
• Experience with CDISC CDASH, SDTM, and CDASH terminology.
• Strong leadership and collaboration across global teams.

Responsabilidades

• Define and maintain standardized data collection definitions aligned with industry standards.
• Lead Therapeutic Area Standards Teams (TASTs) and governance initiatives.
• Support audits and inspections as required.
• Deliver training on data standards to cross-functional teams.
• Engage in industry forums to influence standards evolution.
• Provide governance support for study content and library forms.

Conocimientos

Adaptability

Data Management

Data Standards

Coaching

Mentoring Staff

Project Management

Operational Quality

Process Improvements

Educación

Associate’s degree + 15 years

Bachelor’s Degree + 8 years

Advanced Degree + 4 years

Herramientas

EDC Systems

CDASH

SDTM

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Descripción del empleo

Merck & Co., Inc. seeks an Associate Director to lead data collection data stewardship within Global Data Management and Standards (GDMS) and Global Clinical Data Standards (GCDS). The role guides study teams on data standards, library use and governance, while driving new/modified standards and processes.

Responsibilities include leading Therapeutic Area Standards Teams, delivering training, supporting information governance, tracking conformance, and mentoring staff across global teams.