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Business Analyst, Clinical Trials Job
Eingestellt von Yoh
Gesuchte Skills: Support, Client
Projektbeschreibung
TOP SKILLS YOU SHOULD POSSESS:
- Document Management
- Clinical Trial Master File, (CTMF), or TMF
WHAT YOU'LL BE DOING:
- Accurately files complex, regulatory required, documents into Clinical Trial Master File (CTMF)
- Coordinates with scanning group to ensure accurate filing into CTMF
- Ensures all trial documentation is prepared, accurately filed and saved into CTMF
- Prepares and distributes Investigator Site File (ISF) to sites
- Prepare CTMF documents for inspection readiness
- Coordinate with Document Management System support staff to ensure appropriate data dictionaries are updated for new trials
- Liaise with trial personnel to follow-up on required documentation
- Reconciles trial documents throughout the trial in preparation for trial close-out
- Assists in Clinical Trial Report preparation by linking appendices with Document Management System
- Performs records retention for paper documentation
WHAT YOU NEED TO BRING TO THE TABLE:
- Minimum of three to five (3-5) years administrative, customer service and/or relevant business experience.
- Requires a solid understanding of Clinical Trial master File requirements, Good Clinical Practices, and SOP's, document management system functionality and practices.
- Understanding of Regulatory Compliance and Record Retention policies.
- Familiar with ICH Good Clinical Practices, FDA Good Clinical Practices and other appropriate regulations
BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:
- Familiar with regulatory regulations concerning proper conduct and documentation of a clinical trial
- Ability to use document management and other office systems
- Understanding of Regulatory Compliance and Record Retention policies
OPPORTUNITY IS CALLING, APPLY NOW!
RECRUITER: Chelsea Tevis
Yoh, a DayJ2W: CLINICAL
MONJOBJ2WNECLIN
Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Danbury, 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, Sonstiges