Manager, Data Standards Governance

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POST DATE 9/11/2016
END DATE 10/14/2016

PAREXEL Waltham, MA

Company
PAREXEL
Job Classification
Full Time
Company Ref #
pare-10054864
AJE Ref #
576138208
Location
Waltham, MA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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PAREXEL currently has an opening for an industry leader for a Data Standards Governance Manager (DSGM). Global Data Operations (GDO) provides clinical data services for PAREXEL s Clinical Research Services (CRS) business unit. Services include Biostatistics, Data Management, Clinical Database Programming, Statistical Analysis and Reporting, and Clinical Data Standards Management for the execution of sponsor studies. In this context, PAREXEL uses a Standards Ecosystem, which consists of processes and technology, to develop maintain, govern, utilize and enforce PAREXEL and Client Standards. The Data Standards Governance Manager (DSGM) serves as an owner for selected technologies in the PAREXEL Standards Ecosystem. The DSGM also owns selected client-specific standards. Responsibilities Include:
- Participates and/or co-leads meetings across functions and clients, as needed, relevant to the assigned Systems (MDR/ DCC) and Client Standards
- Collaborates with peers in the standards governance group to manage and maintain content in GDO s Standards Ecosystem
- Leads the definition, implementation and utilization of assigned sponsor data standards
- Performs client-facing activities such as data governance meetings and change control boards
- Participates in the definition and implementation of CDISC standards for PAREXEL
- Acts as subject matter expert for questions related to usage and content of the PAREXEL Standards Ecosystem, especially those the DSGM owns
- Provides technical and data standards leadership and expertise
- Ensure stakeholder management, external client support, and project management for technical aspects supporting data standards and assigned technology
- Works in a project manager role with Clients, Data Standards Analysts, Primary Clinical Data Analysts, Lead Statistical Programmers, and Clinical Database Programmers on client standards
- Leads projects to translate client and PAREXEL requirements into feasible and practical solutions for GDO functional groups using process, operations, and/or technology
- Leading global virtual teams around technology integration and data standards
- Proven ability to manage, independently, competing priorities with attention to detail
- Experience in technical project management
- Ability to work effectively with and motivate virtual teams within different cultural environments
- Ability to negotiate and influence in order to achieve results
- Technical and data standard experience
- Extensive SAS knowledge
- Knowledge and practical understanding of data standards in a clinical trial environment, specifically CDISC models (ODM (Operational Data Model), SDTM (Study Data Enforcement S S A A S S A Metrics S S Tabulation Model), CDASH (Clinical Data Acquisition Standards Harmonization), Define.xml, etc.)
- Knowledge and practical understanding of clinical trial systems (such as EDC (Electronic Data Capture), ePRO (Electronic Patient Reported Outcome), IxRS (Interactive Web Response Systems), or CTMS (Clinical Trial Management System))
- Demonstrated ability to learn new systems and function in an evolving technical environment
- Business process
- Good understanding and experience of clinical trial processes
- Experience in business process redesign and process improvement
- Knowledge of regulatory requirements such as 21 CFR Part 11, and ICH-GCP
- Presentation skills
- Excellent verbal and written communication skills (also in English).
- Strong customer focus (internal and external).
- General skills
- Commitment to quality and quality management
- Ability to adapt to changes in scope and organization
- Sense of urgency Qualifications
- Operational experience required in Data Management, DB Programming and/or Statistical Programming roles
- Experience with clinical database concepts and programming.
- Experience in areas of eClinical Technology or Information Technology project management
- 7 years professional experience
- Experience with external data standards organization (e.g. CDISC)
- Education:
- Bachelor s degree preferably around life sciences and/or computer sciences - and / or equivalent experience. EEO DisclaimerPAREXEL complies with all applicable federal, state, and local laws prohibiting discrimination in employment. All qualified applicants will receive consideration for employment without regard to gender, age, race, color, religious creed, marital status, sexual orientation, national origin, ethnicity, ancestry, citizenship, genetic information, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law.
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