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Job Details

Records Management Administrator

Company: Chiltern
Location: King of Prussia, PA, US
Reference: TL-7125
Closing Date: 20 Sep 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

Records Management Administrator

Requirements:

Job Background

We have an exciting opportunity available for a Records Management Administrator to join our team in the King of Prussia, PA office! The Records Management Administrator will set up, maintain, QC, and transfer paper and electronic Trial Master Files (TMFs) kept by Records Management (RM). The role includes set up of paper files and receipt, QC, query and collation of documents.

This regular, full-time role is office based in King of Prussia, PA.

1. Read and understand project-specific TMF plans.
2. Set up general and site level TMF(s).
3. Assist with creation of the initial expected documents on applicable TMF database.
4. Process paper documents and/or, if an electronic TMF (eTMF), file electronic document; update the applicable TMF database as applicable and required.
5. With guidance from line manager and more-experienced colleagues, raise queries regarding documents received for filing, or where applicable, transmittal forms. Collaborate with appropriate project team member(s) to ensure resolution of queries.
6. Escalate any TMF or eTMF related issues to line manager.
7. Prepare TMFs for transfer.
8. Assist Records Management Specialist or Manager RM with preparation of TMF for internal reviews and audits, sponsor audits, and regulatory inspections. Ensure all documents are filed into the general and site level paper TMF and/or eTMF as applicable.
9. Perform other duties as required by the department.

1. High school diploma or equivalent certificate.
2. Minimum 0 – 2 + years of experience maintaining paper and electronic filing systems, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
3. Ability to maintain confidentiality of employee data and information during interactions with staff at all levels.
4. Proficiency with MS Office Programs.
5. Previous clinical / medical data entry administration experience preferred.
6. Good oral and written communication in both local language and English.
7. Familiarity with the principles of ICH-GCP, relevant parts of CFR21 and other regulatory requirements.


 



Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.

Salary

On Application

Position Type

Permanent
Full Time

Contact

Email Timica Lindsey - Timica.Lindsey@Chiltern.com
+1 423 990 0416

Apply for this job: Records Management Administrator

Contact Information:

Address:  Illinois, USA
1425 Tri-State Parkway, Suite 110 Gurnee, USA
IL 60031
USA
Website:  Visit Our Web Site

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