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Clinical Administrator
Eingestellt von Hays Resource Management - Astrazeneca
Gesuchte Skills: Support, Library
Projektbeschreibung
Location: Astra Zeneca - Horizon Place, Luton
Contract length: ASAP - September 2013
RATE: £13.00 PER HOUR
We are looking for a Clinical Administrator to join us until end of September 2013 for the eTMF (electronic Trial Master File) project. The project entails scanning and uploading documents from a paper TMF to an electronic TMF for 8 ongoing studies.
The ideal candidate:
- Must have excellent attention to detail and drive to achieve the deadline for each of the studies (the work involved will be quite repetitive, we need someone to be able to work quickly but excellent attention to detail)
- Knowledge of essential Clinical Trial documentation and electronic Trial Master File would be preferred but not mandatory
- This role is ideal for someone wanting to get their foot in the door to clinical trial administration
Overall Objective of the Role
The Clinical Administrator contributes to the achievement of the Site Management & Monitoring - Clinical Operations objectives by:
- Providing professional, comprehensive, organizational and system support to the Clinical Administrative function
- Coordinating and delivering the administrative activities associated with the electronic Trial Master File (eTMF) migration project as required for each study to ensure completion of this key deliverable to time, cost and quality objectives
KEY ACCOUNTABILITIES
- Proactive management of all Administrative aspects of the set up and migration of eTMF for applicable studies, and delivery of the associated milestones, targets and activities within the allocated resource/time
- Collaboration with the Clinical Project Leader, Clinical Administration Manager, other SDAs, Clinical Research Managers, and the Clinical Research Associates to ensure that quality and quantity commitments are achieved in a timely and efficient manner
Key Responsibilities
STUDY TRACKING
- Maintain tracking sheets as required for work completed on allocated studies
TRIAL MASTER FILE
- Where required, support the Clinical Project Leader by setting up the local eTMF. Ensure that critical documents are migrated to the centre specific and general sections of eTMF for allocated studies to required quality standards to ensure eTMF is inspection ready
- Support the maintenance of electronic records of study documents
- Ensure study documents are well maintained and handled in accordance with correct procedures in order to minimise the risk to essential documents
- Maintain a comprehensive understanding of the requirements for the processing of study documentation into the eTMF
- Provide regular updates to Clinical Project Leaders and Clinical Administration Manager of eTMF migration status and escalate any issues in a timely manner
- Work with line management and CPrM to address necessary changes and developments in eTMF document management
- Assist with preparation prior to and during audits and inspections
CLINICAL TRIALS MANAGEMENTSYSTEMS
- Migration of documentation into the eTMF for allocated studies
- Support with electronic study documentation and any other electronic systems as required (eg GEL Global Electronic Library)
- Lead the Organisation to deliver productively and reliably
- Support Clinical Administration Manager to provide continuity of logistical services for Site Management ability to respond quickly to shifting demands and opportunities
- Integrity and high ethical standards
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Projektdetails
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Einsatzort:
Luton, Vereinigtes Königreich
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Projektbeginn:
asap
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Projektdauer:
6 months
- Vertragsart:
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Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges