Senior Data Standards Manager
|Job Title:||Senior Data Standards Manager|
|Location:||Union, New Jersey|
|Contact Name:||David Lawrence|
|Job Published:||April 04, 2019 22:04|
You'll be responsible for leading a virtual cross-functional team and improve the global standards in accordance with the company and regulatory requirements. You will be supporting best practice and clinical standards in preclinical epidemiological and clinical studies.
*Lead cross-functional teams and working groups to manage and improve the global data standards used across preclinical, clinical and epidemiological studies. The data standards include eCRFs with associated edit checks and form navigation scripts, underlying EDC database structure, trial design metadata and CDASH to SDTM mappings
*Provides impact assessments and recommendations for non-standard requests and standard updates.
*Act as a member of the Data Standards related governance boards and lead discussion on study specific deviations from Standard in the Data Standards related governance board.
*Provide the datasets and supporting documents (e.g. Define.xml, Reviewers Guide) for CDISC submissions in collaboration with the study team.
*Process owner or delegate of data and metadata standards governance process (SOP and WIs).
*May act as Subject Matter Experts in supporting Business Excellence in the implementation of new processes, trainings, systems, vendor quality assessments, audits and inspections
*Senior clinical standards with experience managing CDISC compliant Data Standards for 4-8 years
*Excellent leadership and coaching skills
*Experience required to deliver the implementation, update and enforcement of data standards in-line with expectations in terms of time and cost and in compliance with DSCS processes
*Experience required to challenge and improve the processes around data standard
*Experienced in Data Management
*Excellent knowledge of CDISC standards (CDASH, SDTM, ADaM)
*Basic understanding of SAS
*Good understanding of regulations including ICH-GCP
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