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Asso. I,TMF Doc. Specialist


Wuhan Shi, Hubei 430015
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Job Details

Position Purpose:

The TMF Document Specialist is responsible for quality control of TMF documents in the PTMF system. The TMF Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of any incomplete, mis-indexed, or inaccurately scanned documents with the Document Owners/TMF Study Owners or other end users.

Major Duties:

Perform quality control on all documents received per In-line QC checks and other reference documents.

- Demonstrate understanding on document types, properties and indexing requirements

- Ensure overall TMF quality by checking document completeness, indexing and scanning accuracy

- Process documents in the TMF system(s) within specified timelines, based on document criticality/priority

- Communicate document inquiries with responsible users as needed

Liaise with Document Owners, TMF Study Owners and/or other end users to resolve document related discrepancies and issues

Communicate, escalate issues to the TMF Document Specialist Lead and TMF Operations

Contribute to process improvements and additional special projects that may arise

Can be identified as a Subject Matter Expert where applicable

Training & Education:

Minimum of a Bachelor's degree or equivalent

Good English skills

Basic computer literacy

Prior Experience Preferred:

Strong oral and written English communications skills

Hands-on experience with electronic documentation management systems and/or web based data management systems. Records management experience in a highly regulated environment (preferably Clinical Research) or experience working with clinical/medical records

Experience/knowledge of ICH/GCP documentation requirements

History of achievement in a customer service role with demonstration of meeting customer needs and concerns

N: Not Applicable - (China)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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