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Clinical Data Manager Job
Eingestellt von Yoh
Gesuchte Skills: Client
Projektbeschreibung
The Big Picture - Top Skills You Should Possess:
- This role delivers expertise in the planning and delivery of Data Management deliverables to time, cost, and quality in partnership with Projects.
- The DMPL plays a key role in the data management (DM) domain, quality, service delivery, issue escalation and governance of DM partners.
- Deliver project level data management activities, technology and standards:
- Develop and deliver strategy and data standards for the high quality DM components across the project(s)
- Review project level DM documentation and specifications as needed to ensure consistency with DM strategies and standards
- Drive the development of Industry Leading Data Standards and Best Practice across Clinical Operations in partnership with Providers, Programming and Strategic Enablement,
- Provide DM technical expertise and consultancy to project and study teams and ensure adoption and adherence to standards
- Responsible for the delivery of high quality clinical data management via external partners
- Contributes to the overall strategy for data management and collaborates with others to drive new holistic strategies across domain areas eg data monitoring and analysis and reporting.
- Provide DM domain advice and direction to the Projects and Operational Functions regarding the DM activities and deliverables to ensure effective delivery of the DM service
- Champions and influences Leadership and Projects to ensure best environment for effective DM Delivery through the Alliance
- Review, access and manage DM delivery to Performance Standards and drive continuous improvement and transformation of practice.
- Working with external partners provide input to the production of the Service Orders and study costs for data management services where needed
- Monitors and manages DM issues and implementation of solutions within
- Ensure study teams utilize project standards by:
- Working with study teams to understand, explain and resolve variances from global and project standards when study requested variances arise
- Working with standards governance organization to handle project (study) standards variance requests
- Lead, coordinate and ensure transparency and consistency of Project, Study and partner activities including providing partners with project planning information (scheduling of the studies, volumes, timelines etc.)
- Input to the DM related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
What You Need to Bring to the Table:
- Bachelors degree is required
- Minimum four (4) years of experience of working in Data Management in the pharmaceutical industry
- Demonstrated comprehensive knowledge and experience of most (or relevant ) aspects of Data Management in the Pharmaceutical industry
- Experience of working successfully to deliver with external partners
- Demonstrated project management skills
- Proven experience in developing tactical/operational plans
- Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP
- Comprehensive knowledge of regulatory requirements as they relate to DM activities
- Comprehensive knowledge of database structures and of capturing and storing clinical information
- Comprehensive knowledge of clinical data standards eg SDTM
- External awareness of DM technologies and technical expertise in industry
- Multi-phase experience in Clinical Research and experience of different Therapeutic Areas
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Krista Leach
Yoh, a DayJ2W: CLINICAL
MONJOBJ2WMIDATL
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Gaithersburg, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung