[KW619] Global Clinical Data Standards Therapeutic Area Lead

[KW619] Global Clinical Data Standards Therapeutic Area Lead

22 mar
|
Merck
|
Buenos Aires

22 mar

Merck

Buenos Aires

Job DescriptionPosition Description:Global Clinical Data Standards Therapeutic Area LeadThe Associate Director, Global Clinical Data Standards Therapeutic Area (GCDS TA) Lead is a subject matter expert in the area of data standards as it relates to developing clinical data collection tools. The individual may be responsible for coordinating data processes related to new therapeutic areas, which may require them to create standards from scratch rather than work to update or change existing standards. Able to work independently or as a team member or leader with equal effectiveness. Interacts with staff across multiple company sites. Mentors, guides, and provides project leadership for junior staff as assigned.



May participate in process design and/or implementation initiatives. The Global Clinical Data Standards Therapeutic Area (GCDS TA) Lead is responsible for:Defining standard collection and mapping data definitions, ensuring alignment with industry (CDISC) standards and Health Authority regulationsEnsuring the definitions are maintained and aligned across the clinical lifecycle (e.g., data collection, analysis & report, and submission) deliverables.Leads standards data governance reviews.Contribute to the definition and maintenance of business processes related to the definition, use, maintenance and sharing of clinical data standards. Led or participate in department initiatives, cross-functional working groups and process improvement activities.Participate in cross-functional project teams; established collaborations/interactions with colleagues outside the department and makes frequent contacts external to the area and/or company.Maintain knowledge of new technologies, industry standards, regulatory requirements,



and our Company's guidelines and SOPs.Able to work independently or as a team member with equal effectiveness. Interacts with staff across multiple Company sites.Position Qualifications: Education Minimum Requirement: B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline; or 8 years of relevant experience.Required Experience and Skills: 8+ years' work experience which includes 4 years of data management experience and a minimum 2 years in clinical data standards development; or advanced degree with 6+ years' work experience of which 2 years need to be in clinical data standards development.Advanced knowledge and leading-edge skills in clinical data standards.Study Data Tabulation Model (SDTM)



expertise.InForm expertise.Analysis & Reporting experienceProgram-level clinical and business requirements knowledge.Communication/presentation skillsEducation/training/facilitation skillsMust have an innovative spirit, outstanding interpersonal skills, leadership and demonstrated proficiency in the management of multiple projects. Knowledge of clinical data management.#EligibleforERP MRLGCTO#ONEGDMSMSJR

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