Records Management Specialist

Records Management Specialist - Archivist
Hybrid 3 days per week in office - Lexington, MA
Purpose
Supports in the administration of Clinical Records Management, ensuring compliance with all appropriate Records Management policies and procedures as well as Records Retention schedule.
The role is intended to maintain the operations of the physical records room(s) regarding archiving, indexing and retrieval of critical and non-critical physical records and so on site work at client site will be required. This also includes the management of off-site records storage activities.
Key Activities

• Supports the administration of the Clinical Records Management Programs ensuring records are managed and maintained according to company policies and procedures, departmental policies/procedures and in accordance with defined retention times and legal holds.
• Provides guidance to maintain the integrity of the archived records. This includes working with staff to determine the best options for their needs—including but not limited to developing and maintaining tracking sheets that fit each document collection and determining the most appropriate location for the physical records (on site or offsite) and the appropriate system for the archiving of scanned/electronic imported records.
• Archival and indexing of critical and non-critical physical records including processing, maintaining, and tracking document collections. In addition, provides guidance on assisting staff with record searches and retrieval requests.
• Archives the Clinical Research physical records stored at external vendors and is the primary contact for offsite storage and retrieval of records.
• Oversees management of the on-site clinical records room and is the primary contact for on-site and timely access of records.
• May support and facilitate records access requirements during regulatory inspection in collaboration with Clinical Document Management and Trial Support and applicable functions.
• Actively manages and maintains the electronic archive database including working with vendor on implementing or updating system.
• Execution of inventories of physical records according to requirements outlined in Clinical Records procedures.
• Satisfactorily completes all required training in conformance with departmental requirements.
• Performs other duties as assigned associated with Records Management initiatives.

 
Required Skills & Experience

• 4+ years' experience in pharmaceutical industry, clinical research organization, or Records Management related role preferred.
• 2+ years of Trial Master File (TMF Management) experience is required
• Awareness of regulatory requirements for clinical trials (ICH/GCP) pertaining to Records Management preferred
• High level of understanding of the use of Microsoft Excel and other Office products
• Demonstrated ability to work with reasonable independence, take initiative, complete tasks to deadlines
• Strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines
• Good communication skills and customer focus
• Good organizational, interpersonal and problem solving skills
• Proven ability to communicate effectively and responding to inquiries and concerns
• Experience with use of electronic Records Management Systems preferred
• Demonstrated ability to be flexible and to adapt quickly to change
• Good teamwork, organizational, interpersonal, and problem solving skills
• Fluent business English (oral and written)
• Able to lift and move boxes of documents

 

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