Become A Document Management Specialist

* Prepares sorts and files source documents and identifies data to be entered.
* Ensures workload is distributed among data entry associates.
* Communicates and complies with deadlines.
* Keeps track of received data and source documents.
* Enters alphabetic numeric or symbolic data from source documents into computer following format displayed on screen and enters necessary codes.
* Compiles sorts and verifies accuracy of data to be entered.
* Contacts preparers of source documents to resolve questions inconsistencies or missing data.
* Reviews error reports and enters corrections into computer to ensure accuracy of data.
* Responds to inquiries regarding entered data.
* Ability to implement processes resulting in satisfactory audit practices

* Reporting to the Clinical Documentation Team Lead, and working in collaboration with the clinical study teams, the Senior Clinical Document Management Specialist is responsible for the management and oversight of Trial Master File(TMF) records from set-up through to final archival of the clinical trial, ensuring compliance with company SOPs and processes, and all applicable regulations
* Focusing on inspection readiness, monitors compliance of the TMF and is responsible for preparation of documentation required for regulatory agency inspection and internal audits
* Oversees set-up and consolidation of outsourced elements of the TMF with preferred CRO vendors.
* With support from the management team, performs periodic quality assessments of clinical TMF documents where required
* Responsible for delivering assigned Clinical Document Management (CDM) initiatives.
* Mentors CDM staff on document management process
* Responsibilities:% of Time Job Function and Description70% Responsible for high quality clinical document deliverables across multiple, global assigned studies in support of FCDO ensuring effective lifecycle management of the clinical section of the TMF.
* Key contributor and member of the clinical study team Monitors completeness and quality of the Clinical TMF, including elements outsourced to CRO Ensures effective communication and issue escalation internally and with external vendors Oversees consolidation and archive preparation of clinical TMF, liaising with CRO partners to ensure compliance with company SOPs and timelines throughout the process May fulfill the role of the Designated Clinical Archivist for GCDO 10% Leads collaboration across R&D to agree to study-specific TMF.
* Oversees the consolidation of the R&D TMF across functions and external vendors at the end of the study
* Supports inspection readiness for GCDO through periodic quality assessment of clinical records Ensures clinical records are filed in a timely manner With direction from the CDM Team Lead, prepares clinical records for agency inspection Manages assigned TMF corrective action plans under direction of CDM Team Lead/Manager 10% Represents CDM by presenting and training on document management processes to functional departments and external vendors

* Day to day quality documentation processing in support of ongoing projects and daily GMP/GDP operations (80%):
* Scope including, but not limited to; SOP’s, Batch Records, Material Specifications, Product Specifications, and Formulation Preparation Sheets
* Assess documentation packages against applicable procedures, processes and guidelines.
* Make edits and review comments to provide to partners globally to ensure compliance.
* Make document processing decisions to ensure compliance to established expectations
* Maintaining filing/ documentation repositories
* Coordinating and assisting with global regions with translation
* Coordinating and assisting managers and document owners with biennial review.
* Coordinate with sites and regions to prepare and maintain the user books as needed.
* Assess impacted documents and associated documents.
* Archival of GMP Records and coordination of Archival activities with Manufacturing groups.
* Generate revision history as needed.
* Balance workloads and make decisions related to prioritization.
* Support and advice end users on document system requirements and workflows.
* Evaluate issues received from end users, make decision on appropriate follow-up steps based on established processes, procedures and guidelines, make decision on escalation to manager as appropriate.
* Enhance and maintain documentation control processes and systems
* o Identify opportunities for process and system improvement and enhancement
* o Participate in quality and process improvement initiatives and project teams.
* o Participate in Integration projects from a document control perspective.
* o Provide support for internal/external audits/and inspections.
* o May assist with documentation metrics reporting.
* May contribute to deviation investigations and CAPAs within scope

Manage and monitor department workflows Ensure all client standards are maintained which includes Turn Around Times (TAT) and Quality Standards per contract Follows Statement of Work (SOW) as described in the contract Continued building of client relationships through exceptional problem-solving, ownership and follow-through, ensuring client inquiries and escalations are handled in a timely and professional manner Supervision of department employees and temporary staff Develop a high performance team by acting as coach and mentor to staff Performance and productivity management Ensure that documents are properly scanned (quality control, adjustment of settings, indexing of pre-selected fields, data transfer

* Become familiar with pertinent aspects of the Contract and Project Team Requirements
* Reads and implements Project
* Specific DM procedures and Work Instructions.
* Indexes and distributes project documents in an accurate and timely manner.
* Issues defined project reports on document status including the Master Document Register.
* Participates in Project Documentation Audits.
* Responsible for identifying DM issues or areas of improvement.
* Provide input in preparing DM Project Status Reports