Manager, Medical Information
ProClinical, in support of our client, are seeking an individual to fill the role of Director of Data Governance, based in Cambridge, MA. The successful candidate will be responsible for leading a cross-functional team of business and technical leaders to establish effective and sustainable data governance operating model over shared enterprise data assets.
- Define and implement a data governance operating model to achieve business objectives.
- Define and communicate roles and responsibilities within data governance.
- Help build understanding of and support for data governance processes.
- Manage data governance presentations, metrics, dashboards, and overall progress communications.
- Identify data domain stewards and formalize data domain stewardship responsibilities.
- Facilitate development and implementation of CDISC standards
- Engage data stewards and coordinate them to achieve defined program goals
- Define and communicate formal standards, policies, and processes.
- Establish repositories for all relevant data and stewardship practices around its maintenance.
- Work with responsible parties to ensure that data standards are in place and that data dictionaries for individual data assets are sufficiently comprehensive, accurate and accessible.
- Build a business glossary and standards around shared data domains.
- Measure, baseline, enhance and sustain data quality improvements over time.
- Facilitate the development and implementation of data standards and data use standards
- Determine if data is appropriate for storage in the data repository. Establish data transmission process.
- Work with vendors to facilitate intake of data.
- Develop eCRF data standards according to CDASH
- Lead implementation of eCRF Global library
- Lead implementation of CDISC data standards
- Work closely with relevant teams to identify and resolve related issues.
- Advance framework, metrics and reporting to guarantee progress can be measured, evaluated, and continually enhanced
Skills And Qualifications
- BA in a science-related field and 8-10 years of experience, preferably in a clinical data or technology role.
- Experience with developing and implementing data governance policies and procedures
- Experience dealing with highly varied data sets.
- Significant experience with development and implementation of data governance standards, processes, and solutions
- Experience with clinical data management, data dictionaries, metadata, and data quality.
- GCP knowledge.
- Strong understanding of clinical trial data.
- Outstanding written, verbal, and interpersonal communication skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Junis Citozi at (+1) 929-388-1650 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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