Merck KGaA

Senior Data Standards Expert (all genders)

Posted On

Sept. 9, 2024

Location

Bangalore, Karnataka

Experience Level

E - Professional (10+ years)

Job Type

full-time or part-time possible

Apply By

Feb. 4, 2025

Job Description

We are seeking a Senior Data Standards Expert to join our dynamic Data Standards & Integration team within the Data Monitoring, Management and Innovation department. As a Senior Data Standards Expert, you will utilize your extensive knowledge of CDISC standards including CDASH, SDTM, and ODM-XML to support our diverse clinical development portfolio. Accountable for creating CRF study metadata for the eDC in compliance with internal and CDISC-CDASH standards, coordinating with stakeholders to optimize data standards and processes Responsible for participating in study set-up activities, including discussions between CRO, internal study teams, and coordinating stakeholder engagements to define and optimize data standards and processes Manage and oversee CRO and vendor performance, including participation in selection/assessment and budget management as required, for assigned trial(s)/projects Contribute to the development, maintenance and optimisation of CRF and Non-CRF data collection standards, and SDTM standards, along with maintaining the standards library in the metadata repository Ensure Submission Readiness for outsourced studies, preparing SDTM packages for marketing authorization submissions and ensuring compliance with submission rules. Foster innovation through new technologies and processes, working with cross-functional colleagues to enhance CRF/Non-CRF and SDTM data standards and procedures in adherence with the governance framework for clinical data standards and change management Contribute to the development and maintenance of data management SOPs, work instructions, and best practices. Who you are: Bachelor's or Master's degree in a scientific or technical discipline, preferably in life sciences, data management, computer sciences or a related field Proven experience in the pharmaceutical/biotechnology industry, equivalent to 10 years and in Data Standards Development and Governance, equivalent to 8 years Minimum of 10 years of experience in Standards Management withData Management or similar discipline within the pharmaceutical, biotechnology, or healthcare industry Committed to continuous personal and professional development, and bringing external insights to the role to drive innovation and process improvement Strong project management, analytical, communication, collaboration, and problem-solving skills Ability to work proactively and independently on assigned tasks or projects of varying complexity Extensive knowledge, and demonstrated experience in implementing CDISC CDASH, SDTM, ODM-XML, and define.xml standards (ADaM knowledge is an advantage)Proven track record in effectively managing data standards projects and aiding their implementation; strong attention to detail and a focus on delivering high-quality and consistent data standards Ability to adapt to evolving CDISC standards / tools and health authorities’ requirements and apply them effectively in practical settings Ability to communicate clearly and concisely, both verbally and in written communication, to effectively convey data standards guidelines and requirementsProficiency with clinical data management systems such as InForm or Rave, specifically in eDC study set-up is preferred English fluent

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