Data Compliance Specialist
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Job description:
Study management at the site level
Maintains ISF and study trackers as delegated and verifies that ICFs are correctly completed.
Assists with data capturing activities on one or more studies across multiple sites and regions.
Ensures accurate and timely entry of all data in the eCRF from the source notes and tracks the flow of the eCRFs and queries.
Verifies protocol visit windows are correct according to the protocol requirements and reports deviations.
Assists monitors and sponsor representatives with query resolutions after monitoring visits.
Understands and adheres to company SOP and COP and assists with input during the review process.
Adheres to the rules and regulations of ICH GCP and other regulatory and ethical guidelines and data protection regulations.
Assists with drafting compliance reports.
Assists in archiving procedures.
Coordinates frequently with monitors and client representatives. Supports preparation of monitoring visit duties and clarifies any expectations relating to CRFs.
Supports audit preparation and audit readiness.
Identifies and escalates common data errors and trends and may assist with CAPA and problem-solving methods.
Cooperation with Vendors
Required Experience:
IC
Key Skills
- GIS
- Computer Data Entry
- Facilities Management
- ADMA
- Fleet
- Key Account
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
