Business Analyst (Clinical Archiving)

Company Name:
Business Analyst (Clinical Archiving)
needed for a
opportunity with Yoh's client located in Danbury, CT.
Top Skills You Should Possess:
- Document Management
- Document Archiving
- Clinical Trial Master File
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 of 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!
Chelsea Tevis
Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer,
Ref: 1034226
Company Description:
For over 70 years, Yoh has provided the talent needed for the jobs and projects critical to client success, by delivering comprehensive workforce solutions that focus on Aerospace & Defense, Engineering, Government, Health Care, Life Sciences, Information Technology and Telecommunications. Yoh fulfills immediate resource needs and delivers managed and outsourced solutions.
Yoh was the nation's first technology staffing firm. As a business unit of Day & Zimmermann, Yoh has a burgeoning global footprint, as our parent company operates from more than 150 worldwide locations. Delivering industry-leading staffing services represents only one facet of our parent company's capabilities, as Day & Zimmermann's companies today provide architectural-engineering-construction services, power plant maintenance and modification services, security services, and validation services to businesses and government agencies, and munitions production, equipment maintenance and facilities management services to the Department of Defense.
Yoh is dedicated to help you achieve your objectives and makes it their business to connect you to the right assignments, provide you valuable feedback during the interview process, and ensure that your personal brand is protected.
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