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Project Lead - Data Management

Eingestellt von Hays Resource Management - Astrazeneca

Projektbeschreibung

DATA MANAGEMENT PROJECT LEAD

LOCATION: Alderley Park

CONTRACT LENGTH: 11 Months

DESCRIPTION

- Located within Clinical Operations in Global Medicines Development
- Required to deliver expertise in the planning and delivery of Data Management deliverables to time, cost, and quality in partnership with Projects
- You will play a key role in the data management (DM) domain, quality, service delivery, issue escalation and governance of DM partners

RESPONSABILITES

- Deliver project level data management activities, technology and 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
- 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
- Assess Clinical DM needs and improvement potential and recommend changes to operating model
- Retain/Build intellectual property as it relates to DM activities/standards for input into strategic decisions (eg input into System and tool strategies)
- Provide input to the provision and prioritization of business requirements for process & technology enhancements partnering with Strategic Enablement for Delivery
- Provide input to the global development and application of DM standards
- Provide strategic DM expertise to Improvement Initiatives
- Lead/input to global DM capability initiatives
- Maintain a constant awareness of trends/changes in external DM Strategies and technologies and advise management on areas of improvement

PERSON REQUIREMENTS

- University degree or equivalent experience
- Significant 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

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Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Hays Resource Management - Astrazeneca